Global Pharmacovigilance Signal Management Senior Associate
4 weeks ago
We are seeking a highly skilled Global Pharmacovigilance Signal Management Sr. Associate to join our team at Eurofins USA PSS Insourcing Solutions. As a key member of our safety team, you will be responsible for performing proactive pharmacovigilance activities to evaluate safety data and signals for marketed products.
Key Responsibilities:- Perform signal detection and safety management committee activities
- Contribute to the review of aggregate safety reports
- Assist with ad hoc regulatory responses
- Facilitate signal management process for assigned products
- Build and maintain technical files within the global signal management system
- B.S. degree required
- Other advanced degree (MS, MPH, PhD) in science such as Biology, Epidemiology, Data Analytics, Regulatory Affairs, or related science is preferred
- Minimum 2 years' experience navigating databases and performing queries, exporting data
- Good knowledge of US and EU pharmacovigilance regulatory requirements with experience in interpretation of regulations, guidelines, and policies preferred
- Experience in preparation of regulatory submissions and knowledge of pharmacovigilance practices preferred
- Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Yearly goal-based bonus & eligibility for merit-based increases
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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