Job Title
Lead Safety Science Specialist
Location
Bangalore, India
Work Mode
Hybrid
Employment Type
Full-time
Job Requisition ID
262138
Application Deadline
June 30, 2026
Role Overview
The Lead Safety Science Specialist is responsible for supporting Clinical Safety and Pharmacovigilance (PV/PSS) operations related to investigational and marketed products. The role involves managing adverse event (AE) processing, expedited reporting, safety data review, pharmacovigilance documentation, and regulatory compliance activities.
The position supports safety operations for clinical trials and post-marketing surveillance while ensuring timely reporting to clients, regulatory authorities, ethics committees, and other stakeholders in compliance with global pharmacovigilance regulations and company SOPs.
Key Responsibilities
1. Adverse Event (AE) & Case Processing
Manage receipt and processing of:
Adverse Event (AE) reports
Serious Adverse Events (SAEs)
Spontaneous and solicited safety reports
Perform:
Safety database entry
Case review
Medical coding
Narrative writing
Follow-up for missing information
Assess events against approved product labels where applicable
2. Expedited Safety Reporting
Submit expedited SAE reports to:
Clients
Regulatory Authorities
Ethics Committees
Investigators
Vendors and partners
Ensure compliance with:
Regulatory timelines
Study-specific reporting timelines
Prioritize cases requiring expedited reporting
3. Pharmacovigilance Reporting
Prepare and support development of:
ICSRs (Individual Case Safety Reports)
Annual IND Reports
ASRs (Annual Safety Reports)
DSURs (Development Safety Update Reports)
Periodic Reports (PRs)
Line listings
Aggregate safety reports
Perform peer review and quality control (QC) of safety reports
4. Safety Data Management & Reconciliation
Support reconciliation activities between:
Safety databases
Data management systems
Maintain understanding of:
Company safety database conventions
Client-specific safety systems and processes
5. Signal Detection & Risk Monitoring
Assist in:
Signal detection
Trend analysis
Pattern recognition activities
Support cumulative safety data review for:
DSMBs (Drug Safety Monitoring Boards)
Regulatory submissions
Client safety reviews
6. SOPs, Compliance & Quality
Maintain compliance with:
GCP guidelines
ICH guidelines
Worldwide pharmacovigilance regulations
Internal SOPs and work instructions
Assist in development and revision of:
SOPs
Work Instructions (WIs)
Safety management documentation
Support audit and inspection readiness activities
7. Study & Project Support
Monitor workflow for assigned studies/programs
Ensure timelines and deliverables are met
Participate in:
Project team meetings
Client meetings
Safety committee activities
Support:
Safety Management Plans (SMPs)
Reconciliation Plans
Endpoint committee coordination
8. Training & Mentoring
Support and train junior safety staff
Provide guidance on:
Case handling
Adverse event reporting
Safety documentation
Share operational and business knowledge across teams
9. Additional Responsibilities
Support proactive issue resolution and CAPA activities
Build collaborative relationships across functional units
Demonstrate company values and role-specific competencies
Perform additional duties assigned by management
Required Qualifications
Education & Experience Requirements
Candidates may qualify through one of the following combinations:
|
Qualification |
Required Experience |
|---|---|
|
Non-degree |
2–3 years safety experience OR 5 years relevant experience |
|
Associate Degree |
2–3 years safety experience OR 4 years relevant experience |
|
BS/BA |
2 years safety experience OR 3–4 years relevant experience |
|
MS/MA |
2 years safety experience OR 2–3 years relevant experience |
|
PharmD |
2 years safety experience OR 2–3 years relevant experience |
For PharmD candidates, a 1-year residency or fellowship may count as relevant experience.
Preferred Educational Background
Degree preferred in:
Biological Sciences
Pharmacy
Nursing
Medical Sciences
Life Sciences
Related healthcare/scientific disciplines
Required Skills & Competencies
Pharmacovigilance & Regulatory Knowledge
Knowledge of:
GCP (Good Clinical Practice)
ICH Guidelines
Global pharmacovigilance regulations
Adverse event reporting requirements
Safety documentation standards
Knowledge of medical and drug terminology
Knowledge of medical device reporting (preferred)
Core Competencies
Strong verbal and written communication skills
Good presentation skills
High attention to detail and accuracy
Strong analytical and problem-solving skills
Ability to work independently with minimal supervision
Team collaboration and cross-functional coordination abilities
Technical Skills
Good keyboard and data entry skills
Proficiency in:
Microsoft Office
Windows-based systems
Safety databases (preferred)
Work Environment
Hybrid office environment
Cross-functional and client-facing role
Compliance-driven clinical safety setting
Compliance & Safety Requirements
Employees are expected to comply with:
Health and Safety at Work Act 1974
COSHH Regulations 1989
EC Directives 1992/3
Company Health & Safety policies and procedures
Role Summary
The Lead Safety Science Specialist is a pharmacovigilance-focused role responsible for adverse event processing, expedited reporting, aggregate safety reporting, regulatory compliance, and safety data management. The position requires strong clinical safety knowledge, attention to detail, and the ability to manage safety operations across clinical and post-marketing environments while supporting regulatory and client requirements.
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 | India | 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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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
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Boise |Colorado :
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 :
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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 :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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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 | Uxbridge | North York | Australia | Richmond Hill | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |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 :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Slovakia | Thailand | Remote - South America (Latin Americal) | Leinster | Hammond | Bishop | Victoria | Remote, USA | Xzagreb | Belgium | Bountiful | Lousiana | Ireland | Castlebar | Green Way | Blue Bell | Medan | Remote - Europe | Springville | McFarland | Zaragoza | Remote | Switzerland | Lenexa | Faridabad | Remote - Middle East | Nairobi | Minnesota | Tulsa | Regulatory Labeling Manager (NA and LATAM Only) | Hungary | Remote - Africa | Manipal | Riga | Texas | Melbourne | French |Republic of Colombia :
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Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
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Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
King Abdullah Economic City | Najran | Khulais | Rabigh | Riyadh | Jeddah |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
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Taipei |Mazovia :
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