Senior Executive – Pharmacovigilance (Aggregate Reporting & Risk Management)
Job Code: PZPV011
Location: Ahmedabad, Gujarat, India
Department: Pharmacovigilance
Job Category: PSMFs | DEA | Aggregate Safety Reporting
Employment Type: Full-Time
Experience Required: 2–4 years
Open Positions: 1
Job Overview
We are seeking a detail-oriented and experienced Senior Executive – Pharmacovigilance to support global safety operations with a strong focus on aggregate safety reporting, risk management documentation, and signal management activities. The role involves close collaboration with cross-functional teams to ensure timely, compliant, and high-quality regulatory safety submissions to global Health Authorities.
This position is well-suited for pharmacovigilance professionals with hands-on experience in PSUR/PBRER, PADER, DSUR, RMPs, and signal management.
Key Responsibilities
Aggregate Safety Reporting
Author and review PSURs/PBRERs, PADERs, Annual Reports, ACOs, and DSURs for submission to local and global Health Authorities.
Ensure aggregate reports meet regulatory standards and submission timelines.
Risk Management & Signal Activities
Author and maintain Risk Management Plans (RMPs) as part of routine pharmacovigilance activities.
Prepare Signal Management Reports, including signal evaluation and documentation.
Literature & Data Review
Perform literature searches and conduct validity checks relevant to aggregate safety reporting.
Extract, validate, and analyze safety data including RSI, sales data, prior reports, RMPs, and signal outputs.
Safety Data Management
Generate Line Listings (LLs) from safety databases.
Reconcile and maintain accuracy of all relevant process trackers and safety documentation.
Operational Support
Provide reliable support for high-priority ad-hoc pharmacovigilance activities as required.
Ensure all deliverables are completed within defined timelines and quality benchmarks.
Required Skills & Competencies
Strong working knowledge of aggregate safety reporting regulations and guidelines
Experience with PSUR/PBRER, PADER, DSUR, RMP, and signal management documentation
Proficiency in safety database data extraction and line listing generation
Excellent documentation, analytical, and regulatory writing skills
Strong time management and ability to handle multiple safety deliverables
Attention to detail and compliance-focused mindset
Qualifications & Experience
Educational Qualification:
Bachelor of Pharmacy (B.Pharm)
Master of Pharmacy (M.Pharm)
Experience:
2 to 4 years of hands-on experience in Pharmacovigilance, with a focus on aggregate reporting and risk management.
Why This Role
Exposure to global regulatory submissions and safety governance
Opportunity to strengthen expertise in aggregate reporting and signal management
Collaborative pharmacovigilance environment with structured processes
Career progression within regulated drug safety operations
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Norway | NOrway |Romania :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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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 :
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Jakarta |East Java :
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Saitama | Japan |Tokyo :
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Ciudad de México | New Mexico |Dubai :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
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