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pharmacovigilance argus mdr ich-gcp gvpπ Description
- Leads global Patient Safety Ops and safety surveillance projects.
- Partners with Clinical Development, Regulatory, Medical Info, Quality, and vendors.
- Ensures compliance with ICH-GCP, regulatory requirements, and SOPs.
- Maintains inspection-ready PV processes and documentation.
- Drives continuous process improvement and quality metrics.
π― Requirements
- Master's in Life Sciences or related; 6β8+ yrs PV exp, or Bachelor's 8+ yrs.
- Progressive experience in pharma/biotech/medical device environments.
- End-to-end case processing and ICSR/MDR lifecycle.
- Safety databases (Argus) and signal detection.
- Global GVP regulations and ICH guidelines knowledge.
- Strong cross-functional collaboration and communication.
π Benefits
- Competitive base salary plus annual bonus.
- Flexible PTO, holidays, and parental leave.
- Healthcare, HSA match, 401k match, insurance.
- Pet insurance and wellness discounts.
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