Senior Pharmacovigilance Specialist
4 weeks ago
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We connect professionals with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.
The ideal candidate will have expertise in authoring aggregate reports for submission to local and other Health Authorities.
We are looking for an experienced Pharmacovigilance Specialist who can ensure all reports are drafted within allocated timelines.
Key Responsibilities:
- Authoring of Aggregate Reports (PSURs/PBRERs, PADERs/Annual Reports/ACO/DSUR)
- Authoring of Risk Management Plans (RMPs) as part of regular Pharmacovigilance activities
- Authoring of Signal Management Reports
- Performing literature search and validity check for the aggregate reports
- Reconciliation of relevant process trackers
- Extraction and validation of data (RSI, Sales, previous reports, RMP, signals)
- Generation of Line Listings (LL) from safety database
- Providing reliable support for high-priority Ad-hoc activities
Requirements:
- Expertise in pharmacovigilance reporting and risk management planning
- Strong analytical and problem-solving skills
- Excellent communication and writing skills
- Able to work independently and manage multiple tasks
Benefits:
- Competitive salary: $70,000 - $90,000 per year
- Opportunities for career growth and professional development
- Bonus structure based on performance
- Paid time off and holidays
About Lifelancer:
Lifelancer is a fast-growing consulting firm specializing in GXP services, regulatory affairs, and pharmacovigilance space.
We offer a dynamic work environment with a talented team of professionals passionate about delivering exceptional results.
Apply now through our website at Lifelancer Careers.
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