Pharmacovigilance Senior Specialist

2 weeks ago

Singapore MSD Full time

Overview Pharmacovigilance Senior Specialist role at MSD . Based in Singapore, the regional hub for Asia Pacific (AP). Our Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to provide safe, effective, innovative medicine. What You Will Do Responsible for adverse event management including aggregate and individual case safety report (ICSR) health authority submissions and compliance monitoring. Manage day-to-day case processing for your assigned product portfolio, ensuring alignment with local laws and regulations. Collaborate with colleagues to adjust schedules and ensure continuous and complete adverse event reporting and drug safety oversight. Serve as the back-up Qualified Person for PV (QPPV) / Local Responsible PV person as required per local PV legislation. Serve as the local health authority contact for PV related questions when assigned. Oversee daily PV processes within the covered country operations and coordinate reconciliation of PV cases from local units and contractual partners. File, store, and archive safety-related and regulatory data in accordance with department and company policies and local requirements. Ensure compliance with global and local SOPs, report deviations or compliance concerns, and assist in CAPA development locally for non-compliance issues. Support local PV audits and inspections, including readiness activities and CAPA responses to findings/observations. Participate in audits of contractual partners/vendors as necessary. Develop and maintain local PV-controlled documents (SOPs, CCPDs, training materials) and ensure they are current. Assist in developing local procedures to ensure global quality PV data and evaluate processes for efficiency improvements. Qualifications Degree in Life Science, medical science or health-related field. Solid pharmaceutical industry experience in Pharmacovigilance/Drug Safety. Good knowledge of PV regulations, processes and activities. Demonstrated supervisory experience managing people, teams, or contractors. Self-motivated with ability to work within established processes. Fluent English (written and spoken) with a collaborative mindset. Ability to build good working relationships and strong organizational/project management skills to handle multiple tasks under time pressure. Proficient in Microsoft Word and Excel; experience with safety databases such as ARGUS is a plus. What You Can Expect Opportunity to have a career with purpose. Work with a passionate Pharmacovigilance and Regulatory Affairs team. Join a company dedicated to making a significant impact on health and lives worldwide. About MSD We are Merck & Co., Inc., Kenilworth, NJ, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life and bringing forward medicines and vaccines to address challenging diseases. Today, we remain at the forefront of research to deliver innovative health solutions. Equal Opportunity We are proud to be an equal opportunity employer, committed to fostering an inclusive and diverse workplace. We encourage colleagues to respectfully challenge one another’s thinking and work together for the common good. #J-18808-Ljbffr

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