📌 Senior Drug Safety Associate | Pune
📍 Location: Pune, India
🕒 Experience: 5 years of relevant experience, including 3 years in drug safety.
💼 Company: EVERSANA
EVERSANA is a global leader in delivering next-generation commercialization services to the life sciences industry, striving to create a healthier world. With a team of more than 7,000 employees across 650 clients, EVERSANA is driven by its mission to improve patient lives around the world.
The Senior Drug Safety Associate supports the Pharmacovigilance (PV) department by processing and analyzing safety data from clinical trials and post-marketing reports. The role involves case management, adverse event tracking, regulatory compliance, and team collaboration.
✔ Collaborate with PV Management/Project Manager to meet project deadlines and ensure timely regulatory reporting.
✔ Independently assess adverse events (AEs) for reportability, expectedness, seriousness, and causality using MedDRA and WHODRUG.
✔ Draft narratives, formulate follow-up queries, and perform Quality Control (QC) checks on the safety database.
✔ Lead and mentor junior team members, ensuring efficient case processing and reporting.
✔ Assist with aggregate reports, ad-hoc reports, and other regulatory documents.
✔ Contribute to regulatory compliance by meeting submission timelines for expedited case reports.
✔ Participate in client interactions, data reconciliation, and training efforts within the team.
🎓 Education: BS degree in a life science discipline (e.g., Pharmacy, Nursing) preferred.
💼 Experience:
EVERSANA prioritizes Diversity, Equity, and Inclusion and is an Equal Opportunity Employer. They are committed to providing a secure and inclusive work environment.
Gujarat :
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Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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China | Quarry Bay |Liaoning :
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Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
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Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Argentina | Peru |Brazil :
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Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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