Pharmacovigilance Specialist

Pharmacovigilance Specialist Get AI-powered advice on this job and more exclusive features. 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 questions and inquiries. The position collaborates with business partners and stakeholders (Outsourced Management Team, Internal/External Manufacturing Sites, Clinical, PV, IT, Local Operating Companies, ESIQ, Call Centers, Brand Protection, QA, Business Quality, Global Medical Safety and R&D) to drive process improvements and deliver effective change management. Assist with various projects within the department and communicate effectively with all levels of management. Educational Attainment: Bachelor’s degree or Master’s degree (preferred) in technical, scientific, or engineering disciplines required. Biomedical Engineer, Registered Pharmacist, Registered Nurse, Physician Assistant or similar healthcare provider/science license/certification/degree preferred. Work Schedule: Day Shift Work Location: Paranaque City/Work from Home Seniority level Mid-Senior level Employment type Other Job function Other Industries Staffing and Recruiting Half of the Qualification portion: 3–5 years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other highly regulated industry. Knowledge of medical safety environment and regulation. #J-18808-Ljbffr