- The Pharmacovigilance Signal Management Sr. Associate will serve as a core member of the safety team and is responsible for performing proactive pharmacovigilance activities to evaluate safety data and signals for marketed products.
- This includes performing signal detection and safety management committee activities, contributing to the review of aggregate safety reports, assisting with ad hoc regulatory responses, facilitating signal management process for assigned products (i.e., executing signal detection queries, signal tracking)
- Build and maintain technical files within the global signal management system
- Utilize technical tools with the Pharmacovigilance suite of software solutions
- Provide innovative ideas and solutions to evolving signal detection and signal management landscape
- 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.
- Problem solver with an ability to take ownership for issues and have the ability to suggest opportunities for continuous improvement
- High level of competency using Microsoft Office suite – with demonstrated high level competence of working in Microsoft Word, Excel, Power BI
- Good organizational skills and attention to detail
- Excellent written and verbal communication skills, fluent in English (verbal and written)
- Ability to evaluate and synthesize scientific data (analytical thinking)
- Team player with ability to function in a cross-functional environment
- Self-motivated, able to prioritize and plan effectively, and independently, with minimal supervision
- Curious, self-starter with a strong interest in data analysis and patient safety
- Pragmatic and agile, with mature business acumen
Position is full-time, first-shift.
Candidates currently living within a commutable distance of Kalamazoo MI are encouraged to apply.
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What we offer:
- 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
- #LI-EB1
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
