Principal Medical Writer, Patient Safety
Location: India (Remote) / Bengaluru, India
Employment Type: Full-Time
Department: Pharmacovigilance / Drug Safety / Medical Writing
Experience Level: Senior / Principal Level
Position Overview
We are seeking an experienced Principal Medical Writer, Patient Safety to provide scientific leadership in the preparation of aggregate safety reports, safety evaluations, risk management documents, and regulatory safety submissions. This role will serve as a subject matter expert (SME) in pharmacovigilance writing, signal management, benefit-risk assessment, and safety analysis, supporting global pharmaceutical, biotechnology, and clinical development programs.
The successful candidate will lead complex safety documentation projects, contribute to strategic safety decision-making, mentor team members, and collaborate with global stakeholders to ensure scientific excellence, regulatory compliance, and high-quality safety deliverables.
Key Responsibilities
Aggregate Safety Reporting & Medical Writing
Lead the preparation, review, and updating of complex aggregate safety reports across multiple products and global regulatory regions.
Author and review key pharmacovigilance and regulatory documents, including:
Periodic Safety Update Reports (PSURs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Periodic Adverse Drug Experience Reports (PADERs)
Development Safety Update Reports (DSURs)
Investigational New Drug Annual Reports (INDARs)
Semi-Annual Safety Reports (SASRs)
Annual Risk-Benefit Evaluation Reports (ARBEs)
Clinical Overviews (COs)
Addenda to Clinical Overviews (ACOs)
Health Hazard Evaluation (HHE) Reports
Safety Statements
Regulatory Response Documents
Ad-hoc Safety Reports
Ensure scientific accuracy, consistency, data integrity, and compliance with global regulatory requirements.
Develop templates, best practices, and document standards for safety reporting activities.
Safety Analysis & Signal Management
Lead advanced signal detection, signal validation, and signal management activities.
Analyze complex safety data from:
Clinical Trials
Post-Marketing Surveillance
Scientific Literature
Global Safety Databases
Identify emerging safety signals and assess potential patient safety risks.
Interpret safety trends and provide recommendations supporting benefit-risk evaluations.
Collaborate with Global Safety Teams to support strategic safety decisions.
Risk Management Planning
Lead development and maintenance of:
Risk Management Plans (RMPs)
Company Core Risk Management Plans (CC-RMPs)
Risk Minimization Strategies
Benefit-Risk Communication Plans
Support responses to regulatory authority questions related to safety and risk management.
Ensure alignment between safety findings, risk management activities, and regulatory expectations.
Literature Review & Scientific Evaluation
Lead literature surveillance strategies and scientific evidence evaluation.
Critically assess published scientific and medical literature for:
Safety Signals
Benefit-Risk Assessments
Regulatory Submissions
Aggregate Reports
Provide scientific interpretations supporting safety documentation and regulatory decision-making.
Regulatory & Scientific Support
Provide strategic scientific expertise across therapeutic areas and product portfolios.
Support regulatory planning, safety strategy development, and submission readiness activities.
Contribute to inspection readiness, audit preparation, and regulatory compliance initiatives.
Represent Medical Writing in cross-functional safety and regulatory discussions.
Client & Stakeholder Management
Lead client interactions for complex safety projects.
Drive scientific discussions, negotiate deliverables, and manage project expectations.
Collaborate with:
Pharmacovigilance Teams
Safety Physicians
Regulatory Affairs
Clinical Development
Biostatistics
Medical Affairs
External Sponsors & Clients
Resolve escalations and ensure high levels of stakeholder satisfaction.
Quality Management & Compliance
Provide quality oversight for global safety documents.
Ensure compliance with:
ICH Guidelines
GVP Requirements
FDA Regulations
EMA Requirements
Global Pharmacovigilance Standards
Lead CAPA implementation and continuous improvement initiatives.
Establish and monitor KPIs and SLAs related to safety writing deliverables.
Support audits and regulatory inspections as a Subject Matter Expert (SME).
Leadership & Team Development
Provide technical leadership and scientific guidance to medical writers and safety professionals.
Mentor and coach team members on:
Safety Writing
Aggregate Reporting
Signal Management
Regulatory Requirements
Identify training needs and drive capability development initiatives.
Foster collaboration, engagement, and knowledge sharing across teams.
Innovation & Technology
Support adoption of innovative technologies and digital solutions within pharmacovigilance operations.
Evaluate AI-enabled and automated tools for safety writing and reporting processes.
Contribute to process optimization and operational excellence initiatives.
Required Qualifications
Education
One of the following:
MD / MBBS
PharmD
M.Pharm
MSc Life Sciences
PhD in Life Sciences, Pharmacy, Biomedical Sciences, or related field
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) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Boulder | Denver | Westminster |Connecticut :
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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 :
Australia | Richmond Hill | North York | Uxbridge | Mississauga | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |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 :
Hà Nội | Hanoi |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 :
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McFarland | Faridabad | Perth | Xzagreb | Remote - South America (Latin Americal) | Springville | Remote - Africa | Bountiful | Manipal | Nairobi | Hungary | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Middle East | Remote - Europe | Leinster | Minnesota | Belgium | Hammond | Riga | Zaragoza | Slovakia | Blue Bell | French | Tulsa | Texas | Lousiana | Medan | Ireland | Lenexa | Castlebar | Switzerland | Victoria | Melbourne | Thailand | Milwaukee | Bishop | Green Way |Republic of Colombia :
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King Abdullah Economic City | Jeddah | Rabigh | Najran | Khulais | Riyadh |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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