Pharmacovigilance Senior Specialist

21 hours 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

  • Pharmacovigilance Specialist

    2 days ago

    Singapore beBeeExpert Full time $90,000 - $120,000

    Job DescriptionThe Senior Drug Safety Specialist will be responsible for managing and performing pharmacovigilance activities, including case intake, tracking, translation to English, acknowledgments, and follow-up activities. This role will also serve as the point of contact for the local Health Authority for PV related questions and ensure compliance with...

  • 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...

  • Pharmacovigilance Senior Specialist

    2 days ago

    Singapore MSD Full time

    **Job Requirements **THE OPPORTUNITY** - Based in Singapore, the regional hub for Asia Pacific (AP) and named one of the Best Companies to Work for in 2019 by HR Asia - Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years. Our Clinical Research and Pharmacovigilance team push the boundaries...

  • Dedicated Pharmacovigilance Professional Wanted

    2 days ago

    Singapore beBeePharmacovigilance Full time $90,000 - $120,000

    Our organization is looking for a dedicated Senior Pharmacovigilance Specialist. The ideal candidate will have experience in pharmacovigilance, strong analytical and communication skills, and the ability to work independently.Responsibilities:Assist in the development and implementation of pharmacovigilance strategiesMonitor and analyze adverse event...

  • Operations Specialist

    1 week ago

    Singapore beBeePharmacovigilance Full time $45,000 - $60,000

    Job DescriptionWe are seeking a highly skilled and motivated professional to fill the role of Operations Specialist. The ideal candidate will have a strong background in pharmacovigilance, excellent communication skills, and the ability to work independently.The Operations Specialist will be responsible for reviewing, assessing, and processing safety data...

  • Senior Specialist, Drug Safety

    2 days ago

    Singapore Organon Full time

    **The Position** The Senior Drug Safety Specialist is responsible for all assigned pharmacovigilance activities and may serve as the point of contact with local stakeholders, headquarters and the local health authority. Reporting to the Associate Director Drug Safety based in Melbourne, Australia, the Senior Drug Safety Specialist collaborates with...

  • Regulatory Affairs cum Pharmacovigilance OR Quality Management Control Manager

    2 days ago

    Singapore PharmaLex Full time

    Regulatory Affairs cum Pharmacovigilance OR Quality Management Control Manager Join to apply for the Regulatory Affairs cum Pharmacovigilance OR Quality Management Control Manager role at PharmaLex. Overview Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person...

  • Drug Safety Leader

    4 days ago

    Singapore beBeeSpecialist Full time $90,000 - $120,000

    Job DescriptionThe Senior Pharmacovigilance Specialist is a critical role in ensuring the safety of our products and adhering to regulatory requirements. The ideal candidate will have extensive knowledge of pharmacovigilance principles, regulations, and guidelines.Manage and coordinate pharmacovigilance activities, including case intake, tracking, and...

  • Patient Safety Specialist

    7 days ago

    Singapore INTEGRITY PARTNERS PTE. LTD. Full time

    Exciting opportunity alert! A leading global pharmaceutical company at the forefront of scientific research, dedicated to addressing critical medical needs, is on the lookout for a **Patient Safety Specialist **to join their dynamic team. In this role, you'll be pivotal in driving pharmacovigilance activities, encompassing individual case safety report...

  • Senior Pharmaceutical Safety Professional

    2 weeks ago

    Singapore beBeeDrugSafety Full time $90,000 - $120,000

    Pharmacovigilance Specialist Role\Our Pharmacovigilance and Regulatory Affairs team pushes the boundaries of global healthcare through research and innovation. We are committed to ensuring the safety and efficacy of our existing and pipeline products to provide safe, effective, innovative medicine.\This role involves managing adverse event reporting and drug...