Sr. Pharmacovigilance Clinical Scientist
$135,200–$135,200 year
HybridSouth San Francisco, California, United States
Job Summary
Conduct clinical review and quality assessment of Individual Case Safety Reports and adverse events, evaluating case validity, causality, and follow-up requirements. Ensure accurate case processing in the global safety database while monitoring quality trends, vendor performance, and compliance risks. Support PV regulations including FDA, ICH, EMA, and GVP standards through labeling assessments, Health Authority submissions, and vendor oversight activities. Lead process improvements, SOP updates, and training initiatives for internal and external teams. Prepare scientific documentation and presentations for cross-functional collaboration. Requires healthcare professional degree and 5–7+ years in biopharmaceutical safety. Long-term contract at $65/hr on W2 in South San Francisco, CA.
Required Qualifications
- Healthcare professional degree such as RN/BSN/MSN, PharmD, RPh/BPharm, NP, MD, or related qualification.
- 5–7+ years of pharmacovigilance experience in a biopharmaceutical environment or equivalent clinical experience with strong knowledge of safety regulations.
- Strong experience with ICSR case processing and clinical review.
- Knowledge of FDA, ICH, EMA, GVP, and global pharmacovigilance regulations.
- Experience with medical/scientific writing, data entry, and project management.
- Strong analytical, communication, organizational, and problem-solving skills.
- Ability to work independently, manage complex issues, and collaborate effectively with internal teams and external vendors.
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