Lead Safety Science Specialist (Pharmacovigilance)
Location: Bangalore, India
Employment Type: Full-Time (Hybrid)
Job ID: 262138
Job Overview
The Lead Safety Science Specialist supports clinical safety and post-marketing safety (PSS) operations, including end-to-end adverse event (AE) processing across clinical trials and real-world settings.
This role is responsible for ensuring accurate, timely, and compliant processing of safety data, including submission of adverse event reports to clients, regulatory authorities, and other stakeholders in accordance with applicable regulations and timelines.
The role ensures high-quality pharmacovigilance operations aligned with company SOPs, global regulatory requirements, and industry standards.
Key Responsibilities
Adverse Event Processing
Receive, review, and process adverse event reports from clinical trials and spontaneous sources
Enter AE data into safety databases and perform case assessment, coding, and narrative writing
Follow up on missing or incomplete safety information
Assess cases for regulatory reporting requirements based on product labeling (where applicable)
Regulatory Reporting & Submissions
Prepare and submit expedited Serious Adverse Event (SAE) reports to clients, regulatory authorities, ethics committees, investigators, and vendors within required timelines
Ensure timely reporting to global regulatory agencies in compliance with study and regulatory requirements
Prepare pharmacovigilance outputs including:
Individual Case Safety Reports (ICSRs)
Annual IND reports
Development Safety Update Reports (DSURs)
Annual Safety Reports (ASRs)
Periodic reports and line listings
Quality & Compliance
Perform peer or independent quality control (QC) of safety reports
Ensure adherence to pharmacovigilance SOPs, work instructions, and regulatory guidelines
Support audit and inspection readiness activities
Assist in resolving quality issues and implementing corrective actions
Safety Operations & Analysis
Support signal detection, trend, and safety pattern analysis activities
Assist in safety data reconciliation with data management or clients
Monitor workflow to ensure compliance with safety reporting timelines
Contribute to safety committee and DSMB (Data Safety Monitoring Board) activities
Documentation & Process Improvement
Assist in developing Safety Management Plans (SMPs), reconciliation plans, and related documents
Contribute to SOP and work instruction development and updates
Participate in generating monthly and study-specific safety metrics reports
Ensure accuracy and quality of safety data reporting outputs
Collaboration & Communication
Work closely with cross-functional teams, including clinical operations, data management, and regulatory teams
Participate in client and project meetings
Communicate effectively with internal and external stakeholders
Support training and mentoring of junior safety staff
Qualifications
Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related field preferred
Equivalent combinations of education and experience may be considered
Experience Requirements (varies by qualification):
Non-degree: 5 years relevant experience OR 2–3 years safety experience
Associate degree: 4 years relevant experience OR 2–3 years safety experience
Bachelor’s degree: 3–4 years relevant experience OR 2 years safety experience
Master’s/PharmD: 2–3 years safety experience or relevant experience
Required Skills & Knowledge
Strong written and verbal communication skills
High attention to detail and accuracy
Ability to work independently and within cross-functional teams
Knowledge of medical terminology and drug safety concepts
Understanding of Good Clinical Practice (GCP) and ICH guidelines
Familiarity with global pharmacovigilance regulations
Strong analytical and problem-solving skills
Proficiency in MS Office tools
Preferred Skills
Knowledge of medical device safety reporting (advantageous)
Experience working in global pharmacovigilance environments
Ability to manage multiple priorities in a regulated, deadline-driven setting
Work Environment
Office-based environment (hybrid setup)
Requires high attention to detail and sustained computer-based work
Must be able to manage multiple priorities and deadlines
Role Summary
This role plays a critical part in ensuring patient safety through accurate and timely adverse event reporting. It requires strong pharmacovigilance expertise, regulatory awareness, and the ability to operate effectively in a highly regulated clinical safety environment.
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) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Mexico |northeastern :
New Hampshire |Oklahoma :
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Washington |Delaware :
Wilmington |North Rhine Westphalia :
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Bavaria |Bavaria :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Saarbrucken |Switzerland :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
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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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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 :
Richmond Hill | Australia | North York | Mississauga | Uxbridge | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |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 :
Estonia | Tartu |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 :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Buenos Aires |Republic of Egypt :
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New Mexico | Ciudad de México |Dubai :
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King Abdullah Economic City | Riyadh | Rabigh | Najran | Jeddah | Khulais |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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