Pharmacovigilance Senior Specialist

4 days 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

  • Quality and Regulatory Affairs Specialist

    1 week ago

    Singapore MAJETON PTE. LTD. Full time

    At Majeton, weare driven by our commitment to deliver “The Right Product for Health”. Our team of researchers and clinical experts utilize clinic feedback from practitioners, scientifically researched literature and top quality manufacturing as the foundation for all products. We are seeking a meticulous and experienced Quality & Regulatory Affairs...

  • Quality and Regulatory Affairs Specialist

    24 hours ago

    Singapore MAJETON PTE. LTD. Full time

    At Majeton, weare driven by our commitment to deliver "The Right Product for Health". Our team of researchers and clinical experts utilize clinic feedback from practitioners, scientifically researched literature and top quality manufacturing as the foundation for all products. We are seeking a meticulous and experienced Quality & Regulatory Affairs...

  • Senior Drug Safety Specialist

    1 week ago

    Singapore MSD Full time $80,000 - $120,000 per year

    Job DescriptionSenior Drug Safety Specialist THE OPPORTUNITYOpportunity to be a part of the Strategic Partnerships team in SingaporeBased in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on The Straits Times and Statista's list of Best Employers in Singapore for four consecutive years (2020, 2021, 2022, 2023) as...

  • Clinical Specialist

    2 weeks ago

    Singapore Medtronic Full time

    Join to apply for the Clinical Specialist role at Medtronic Join to apply for the Clinical Specialist role at Medtronic Get AI-powered advice on this job and more exclusive features. At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking...

  • Senior/ Regulatory Specialist

    4 days ago

    Singapore Health Sciences Authority Full time

    **What the role is** - Post-market vigilance and safety monitoring to ensure the continued safety and quality of marketed health product, including instituting timely and appropriate regulatory actions to ensure the safe and appropriate use of health products. - Develop and implement Good Pharmacovigilance Practice (GVP) compliance framework and conduct GVP...

  • Senior Pharmacist, Regulatory Affair

    1 week ago

    Singapore MANADR PTE. LTD. Full time

    Tele-pharmacy Patient Support Program: execute and manage the program. The training and supervision of pharmacy staff - Controlled Drugs: receive and issue controlled drugs, maintenance of manual records and reporting to the authority. - Procurement: To work with vendors in the procurement of pharmaceutical products required by the company - Inventory and...

  • Safety & Pv Specialist I

    2 weeks ago

    Singapore Syneos Health Clinical Full time

    **Description** **Safety & Pharmacovigilance Specialist I** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value...

  • Senior Pv Executive

    4 days ago

    Singapore INTEGRITY PARTNERS PTE. LTD. Full time

    Global Pharmaceutical MNC - Strong portfolio of products across multiple therapeutic areas (e.g. Oncology, Immunology, Cardiovascular Disease) - Risk Management Plans/Risk Minimization Activities **Main Responsibilities**: The successful incumbent will be tasked to perform and contribute to pharmacovigilance activities such as individual case safety report...

  • Senior Regulatory Pharmacist

    23 hours ago

    Singapore Zuellig Pharma Full time

    Get AI-powered advice on this job and more exclusive features. About Us Zuellig Pharma is a leading healthcare solutions company in Asia, dedicated to making healthcare more accessible to the communities we serve. We provide world-class distribution, digital, and commercial services to support the growing healthcare needs in this region. Founded a century...

  • Specialist / Senior Specialist (LSN)

    2 weeks ago

    Singapore Care Corner Full time

    Specialist / Senior Specialist (LSN) page is loaded## Specialist / Senior Specialist (LSN)remote type: Hybridlocations: Singaporetime type: Full timeposted on: Posted 9 Days Agotime left to apply: End Date: November 9, 2025 (20 days left to apply)job requisition id: JR-00006**Specialist / Senior Specialist (Learning and Special Needs)**Care Corner Learning...