CS Writing Scientist
Job Details
Company: Haleon
Location: Hyderabad Connaissance Park, Hyderabad, India
Employment Type: Full-time
Job Requisition ID: 547536
Job Posting End Date: September 15, 2026
Functional Area: Consumer Safety / Pharmacovigilance
Preferred Experience: Minimum 5 years of relevant experience
Preferred Qualification: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related scientific discipline
Role Overview
The Consumer Safety Writing Scientist is responsible for planning, authoring, coordinating, quality reviewing, and delivering pharmacovigilance aggregate safety reports in accordance with global, regional, and local regulatory requirements.
The role ensures that safety reports are scientifically accurate, balanced, compliant, timely, and inspection-ready. The position supports ongoing benefit-risk evaluation and helps fulfil Marketing Authorisation Holder (MAH) pharmacovigilance obligations.
Position Purpose
The role leads the end-to-end preparation and delivery of pharmacovigilance aggregate safety reports for regulatory submission.
The position holder will prepare scientifically balanced, compliant, and fit-for-purpose safety documents, including:
Periodic Safety Update Reports (PSURs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Development Safety Update Reports (DSURs)
Medical Device Periodic Safety Update Reports
Canadian Annual Reports
US Periodic Adverse Drug Experience Reports (PADERs)
Other periodic or ad hoc aggregate safety reports, as applicable
The role requires close collaboration with Consumer Safety Science, Regulatory Affairs, Medical, Clinical, Labelling, and other contributing functions to ensure accurate safety data interpretation, robust benefit-risk assessment, and timely report completion.
Key Responsibilities
Aggregate Safety Report Management
Plan, author, coordinate, review, and finalize pharmacovigilance aggregate safety reports from initiation through completion.
Ensure scientific accuracy and regulatory compliance of assigned reports.
Deliver reports according to agreed timelines and business requirements.
Coordinate contributions from relevant internal stakeholders.
Ensure reports are complete, consistent, scientifically balanced, and fit for regulatory submission.
Manage multiple aggregate reporting deliverables simultaneously.
Safety Data Compilation and Assessment
Compile, assess, and integrate relevant safety data from multiple sources.
Review information from:
Safety databases
Clinical data
Scientific literature
Regulatory commitments
Previous aggregate reports
Approved reference documents
Assess safety information for relevance, consistency, and completeness.
Interpret safety data to support aggregate report conclusions.
Identify relevant safety information requiring discussion within aggregate reports.
Literature Review and Signal Identification
Review scientific literature and relevant safety information.
Identify emerging safety topics and potential signals.
Determine whether identified safety information requires inclusion or discussion in aggregate reports.
Support safety signal evaluation through appropriate data interpretation.
Collaborate with Consumer Safety Science and other functions on emerging safety concerns.
Scientific Writing
Develop clear and scientifically balanced safety narratives.
Prepare executive summaries and report conclusions.
Present complex safety information in a clear and scientifically appropriate manner.
Ensure conclusions are supported by available safety data.
Provide scientifically sound content for:
Aggregate safety reports
Regulatory responses
Internal decision-making
External communications
Benefit-risk assessments
Benefit-Risk Evaluation
Provide aggregate reporting expertise to Consumer Safety Science.
Contribute to benefit-risk assessments.
Support evaluation of safety signals and safety topics.
Contribute to safety surveillance activities.
Support labelling updates where safety information impacts product information.
Ensure aggregate report strategy and content appropriately reflect the overall benefit-risk profile.
Product Safety Knowledge
Maintain current knowledge of assigned products and their safety profiles.
Ensure consistent and accurate use of approved product safety information.
Apply approved safety information consistently across aggregate reports and related regulatory documents.
Maintain awareness of relevant product-specific regulatory and safety requirements.
Quality Control and Inspection Readiness
Maintain audit and inspection readiness for assigned reports.
Ensure complete and traceable documentation.
Maintain clear rationale for key decisions and conclusions.
Ensure data sources are appropriately documented and traceable.
Maintain controlled document versions.
Ensure appropriate quality control evidence is available.
Ensure assigned reports meet company quality standards and regulatory expectations.
Stakeholder Management
Collaborate closely with Consumer Safety Science.
Work with Regulatory Affairs on regulatory requirements and submissions.
Collaborate with Medical and Clinical functions on scientific and clinical content.
Work with Labelling teams when safety information affects product labelling.
Coordinate with other contributing functions to obtain required data and inputs.
Independently resolve content and process issues with stakeholders.
Challenge stakeholder inputs when scientifically or procedurally appropriate.
Ensure stakeholder contributions are delivered within agreed timelines.
Process Improvement
Drive improvements in aggregate report writing processes.
Improve report templates and quality standards.
Develop and promote consistent ways of working.
Identify opportunities to improve efficiency and quality.
Support initiatives focused on:
Consistency
Efficiency
Compliance
Quality
Inspection readiness
Regulatory and Compliance Responsibilities
Ensure aggregate reports comply with applicable global, regional, and local regulatory requirements.
Maintain awareness of aggregate reporting expectations.
Ensure reports fulfil Marketing Authorisation Holder pharmacovigilance obligations.
Support timely regulatory submission of assigned reports.
Ensure report content is scientifically balanced and supported by appropriate evidence.
Maintain appropriate documentation for regulatory and inspection purposes.
Required Qualifications
Bachelor’s degree in Pharmacy, Life Sciences, or a related scientific discipline; or
Master’s degree in Pharmacy, Life Sciences, or a related scientific discipline.
Required Experience
Minimum 5 years of relevant professional experience is preferred.
Experience in pharmacovigilance and drug safety is highly relevant.
Experience preparing and reviewing pharmacovigilance aggregate safety reports.
Experience with periodic safety reporting and safety data analysis.
Experience working with cross-functional stakeholders in a regulated pharmaceutical or healthcare environment.
Technical Skills
Strong pharmacovigilance knowledge.
Experience with aggregate safety reporting.
Knowledge of PSUR/PBRER preparation and review.
Knowledge of DSURs and other periodic safety reports.
Understanding of medical device safety reporting is advantageous.
Knowledge of pharmacovigilance principles.
Knowledge of MedDRA terminology.
Understanding of medical and clinical concepts.
Knowledge of aggregate reporting requirements.
Understanding of benefit-risk evaluation.
Ability to interpret and analyze safety data.
Ability to identify and evaluate safety topics and potential signals.
Strong documentation practices.
Proficiency in Microsoft Office applications.
Scientific Writing Skills
Excellent written English.
Strong scientific writing capabilities.
Ability to prepare clear, concise, and scientifically balanced narratives.
Ability to communicate complex safety information effectively.
Ability to develop evidence-based conclusions and executive summaries.
Strong attention to detail and document quality.
Soft Skills and Behavioral Competencies
Strong communication skills.
Strong stakeholder engagement capabilities.
Ability to work independently with limited supervision.
Strong organizational and time-management skills.
Ability to manage multiple deliverables simultaneously.
Ability to manage competing priorities.
Ability to work effectively under regulatory deadlines.
Self-motivated and proactive approach.
Adaptability to changing timelines and business priorities.
Strong attention to detail.
Ability to challenge inputs constructively.
Strong collaboration and problem-solving skills.
Key Deliverables
The position may be responsible for the preparation, review, coordination, and finalization of:
PSURs
PBRERs
DSURs
Medical Device PSURs
Canadian Annual Reports
US PADERs
Other periodic safety reports
Ad hoc aggregate safety reports
Safety narratives
Executive summaries
Benefit-risk assessment content
Regulatory responses
Safety-related supporting documentation
Core Competencies
Pharmacovigilance
Aggregate safety reporting
Drug safety
Consumer safety
Scientific writing
Safety data analysis
Benefit-risk assessment
Signal evaluation
MedDRA
Regulatory compliance
Literature review
Medical and scientific concepts
Quality control
Inspection readiness
Stakeholder management
Cross-functional collaboration
Project and timeline management
Process improvement
Role Expectations
The CS Writing Scientist is expected to independently manage complex aggregate reporting activities while maintaining high standards of scientific accuracy, regulatory compliance, and document quality.
The role requires strong ownership of deliverables, effective stakeholder coordination, the ability to interpret safety data, and the judgment to challenge or escalate issues when appropriate.
The successful candidate should be able to balance multiple regulatory deadlines while maintaining accuracy, consistency, traceability, and inspection readiness.
About Haleon
Haleon is a consumer health company focused on improving everyday health through a combination of scientific expertise and understanding of consumer needs. Its portfolio includes brands such as Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum.
The organization emphasizes innovation, collaboration, inclusion, professional development, and creating meaningful health outcomes for consumers globally.
Equal Opportunities
Haleon is committed to creating an inclusive workplace where diverse backgrounds, perspectives, and experiences are valued and respected. Employment decisions are made fairly and without discrimination.
Adjustments and Accommodations
Candidates requiring reasonable adjustments or accommodations during the recruitment process can contact their recruiter and provide details of the specific support required. Haleon states that such information will be handled confidentially.
Candidate Communication
Candidates should be aware that Haleon’s recruitment team will contact applicants using an official @haleon.com email account. Candidates should verify the source of any recruitment communication if they are uncertain about its authenticity.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |New Mexico :
Albuquerque | Farmington | Santa Fe | Tucumcari |Pennsylvania :
Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Pottstown | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |LA :
Baton Rouge | Monroe | New Orleans |Washington :
Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
Bloomington | West Lafayette |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
Charleston |Kansas :
Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | Australia | Richmond Hill | North York | Renfrew | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Yavne | Kfar Saba | Be'Er Sheva | Tel Aviv | Netanya |Remote :
Remote - South America (Latin Americal) | Switzerland | Bountiful | Victoria | Castlebar | Milwaukee | Thailand | Lousiana | Faridabad | Melbourne | Tulsa | Green Way | Riga | Hungary | Remote - Middle East | Lenexa | Manipal | Minnesota | Medan | Perth | Bishop | Regulatory Labeling Manager (NA and LATAM Only) | Texas | Blue Bell | Ireland | Slovakia | French | Belgium | McFarland | Nairobi | Springville | Hammond | Xzagreb | Remote - Europe | Leinster | Zaragoza | Remote - Africa |Republic of Colombia :
Bogota |Williamson :
Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Riyadh | Khulais | Jeddah | King Abdullah Economic City | Rabigh | Najran |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |