Job Title: Pharmacovigilance Compliance Associate
A leading biopharmaceutical company in the Bay Area is seeking a Pharmacovigilance Compliance Associate who will assist the Drug Safety/PV department with monitoring and oversight of Drug Safety activities.
Responsibilities:
- Oversee and monitor Drug Safety and Pharmacovigilance compliance activities
- Facilitate activities, document reviews, and schedule meetings between departments and outside parties
- Assist with preparation of training's, ICSR submission, aggregate report submission, quality events
- Maintain knowledge of ICH, FDA, and global regulatory guidelines
- Documents management and administrative support (maintaining department SharePoint site)
- Create and review SOP's and other procedural documents
Qualifications:
- 3+ years Drug Safety/PV industry experience
- Experience with Argus, ARISg preferred
- Strong administrative and coordination abilities
Benefits:
- Excellent work/life balance
- Opportunities to learn cross-functionally
- Dedicated programs and foundations working to give back to the community
- Programs that support a diverse and inclusive workforce
If this seems of interest to you, please don't hesitate to apply!
