Pharmacovigilance Senior Specialist

MSD; Singapore; On-site; SGD 70,000 - 90,000; Full time

Benefits offered by this job

Opportunity for career growth

Inclusive workplace

Impact on global health

Job summary

A leading global healthcare company is seeking a Pharmacovigilance Senior Specialist in Singapore. The role involves managing adverse event reports, ensuring compliance with regulations, and supporting local audits. Candidates should have a degree in a related field and experience in drug safety. This position offers the chance to work in a passionate team dedicated to health innovation.

Qualifications

• Solid pharmaceutical industry experience in Pharmacovigilance/Drug Safety.
• Good knowledge of PV regulations, processes, and activities.
• Self-motivated with the ability to work within established processes.

Responsibilities

• Responsible for adverse event management including ICSR submissions.
• Manage day-to-day case processing for assigned products.
• Serve as local health authority contact for PV related questions.

Skills

Pharmacovigilance experience

Regulatory compliance knowledge

Team management

Project management skills

Fluent English

Microsoft Word and Excel proficiency

Education

Degree in Life Science or health-related field

Tools

Safety databases (e.g., ARGUS)

Job description

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.