Pharmacovigilance Senior Specialist

About the Role and Company

This position is based in Singapore, the Asia Pacific regional hub, recognized as one of the best workplaces by HR Asia in 2019. The employer is a leading biopharmaceutical company with legacy of over 25 years in Singapore and more than 60 years in the Asia Pacific region.

The Clinical Research and Pharmacovigilance team is dedicated to enhancing global healthcare through research and innovation, ensuring the safety and effectiveness of current and future medications through clinical trials and monitoring.

Key Responsibilities

• Act as the deputy Qualified Person for Pharmacovigilance (QPPV) or Local Responsible PV representative as mandated by local regulations.
• Serve as the contact point for local health authorities regarding pharmacovigilance queries when assigned.
• Oversee daily pharmacovigilance processes and activities in the assigned countries.
• Coordinate reconciliation of PV cases received from local units and external partners, ensuring compliance with local procedures and pharmacovigilance laws.
• Manage filing, storage, and archiving of safety and regulatory documentation in line with company policies and local rules.
• Strictly adhere to global and local SOPs; promptly report deviations or compliance issues and assist in developing corrective and preventive actions for non-compliance.
• Act as subject matter expert supporting local PV audits and inspections; assist in preparing CAPAs to address findings and cooperate during audits of contractual partners or vendors.
• Develop and keep current local PV-controlled documents such as SOPs, training materials, and other procedural documents.
• Support creation of local procedures compliant with regional and global standards to ensure high-quality PV data and seek process enhancements to improve efficiency.

Required Experience and Skills

• Degree in Life Science, Medical Science, or a related health discipline.
• Proven experience in the pharmaceutical industry with a focus on Pharmacovigilance or Drug Safety.
• Solid understanding of pharmacovigilance regulations, processes, and operations.
• Experience supervising teams or managing contractors.
• Self-driven with the capability to manage processes effectively.
• Excellent spoken and written English communication skills combined with a cooperative approach.
• Strong ability to establish productive working relationships.
• Organized with skills in managing multiple projects under pressure.
• Proficiency in Microsoft Word and Excel.
• Hands-on experience with safety databases such as ARGUS.

What to Expect

• Opportunity to contribute to meaningful career work focused on improving global health.
• Collaborate with a dedicated Pharmacovigilance and Regulatory Affairs team.
• Work for a company committed to scientific innovation to create medicines and vaccines that positively affect lives worldwide.

Company Overview

Known globally as MSD outside the US and Canada, this leading biopharmaceutical company has a rich history of nearly a century in developing medicines and vaccines addressing some of the world's most challenging diseases. The organization fosters a research-driven culture with a mission to innovate for patient benefit and enhance prevention and treatment strategies globally.

Inclusive Culture and Recruitment Note

The company values diversity and encourages inclusive collaboration, where varied ideas are respected to foster innovation. It is an equal opportunity employer, aiming to build teams with diverse talents and backgrounds.

This recruitment is part of a talent pipeline initiative for upcoming roles aligned with the Pharmacovigilance function described here. Applicants express interest for potential future opportunities.