Job Summary
A company is looking for a Senior Manager, Pharmacovigilance Scientist.
Key Responsibilities
- Oversee all pharmacovigilance activities for assigned compounds, ensuring safety surveillance and regulatory compliance
- Assist in Medical Safety Review Committee meetings and represent Drug Safety & Pharmacovigilance on cross-functional teams
- Develop safety strategies and maintain relevant SOPs while providing expertise in pharmacovigilance operations
Required Qualifications
- 6+ years of relevant experience in pharmacovigilance or a related medical field with an RN/BSN/PharmD/PhD/MD degree
- Clinical or industry experience in nephrology and antibodies is preferred
- Experience as a Subject Matter Expert in audits/inspections and mentoring colleagues
- Familiarity with PSURs, DSURs, and safety documentation in clinical development
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