We are seeking a Manager, Pharmacovigilance to support safety oversight of both marketed and pipeline products. This role will be responsible for case processing, safety evaluations, signal detection, and regulatory reporting. The position requires strong knowledge of global drug safety regulations, case management, and signal detection practices.
Responsibilities:
Collect, assess, and process adverse event reports (clinical and post-marketing).
Ensure timely case entry, follow-up, and submission to regulatory authorities (FDA, EMA, etc.).
Support signal detection activities, data analysis, and preparation of safety reports.
Maintain compliance with evolving global pharmacovigilance requirements.
Train internal/external staff on PV requirements when needed.
Contribute to safety-related audits, inspections, and partner collaborations.
Assist with PV activities for clinical trials, business development, and cross-functional initiatives.
Required Qualifications:
BS in Life Sciences, Pharmacy, or Nursing (MS/PharmD preferred).
Strong knowledge of GVP, GCP/ICH, case processing, and signal detection.
Opportunity Awaits.
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