Pharmacovigilance Specialist

Pharmacovigilance Specialist

• 3-5 years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related highly regulated industry.
• Knowledge of medical safety environment and regulation.

Essential Duties and Responsibilities

• Document and review malfunction MDR data fields and potentially Vigilance Reports (i.e. MDV, MPR) as required. This includes providing the completed data fields to Medical Safety to support on-time filing of initial and supplemental regulatory reports.
• Evaluate reportable regulatory decisions to ensure accuracy and document written justification to support reportable regulatory decisions.
• Perform end to end complaint handling activities for Combination Products as requested.
• Serve as a PQV (Product Quality Vigilance) point person for post market and complaint handling regulatory ...