Pharmacovigilance (PV) Manager (Regional)

5 days ago

Singapore DAIICHI SANKYO SINGAPORE PTE. LTD. Full time
The Pharmacovigilance (PV) Affiliate Manager and Cluster Lead (Singapore/Australia) is a PV cluster lead position overseeing local PV system in the assigned countries (i.e. Singapore, Australia) as a local PV responsible person, and is responsible for ensuring compliance with relevant pharmacovigilance (PV) regulatory requirements globally and locally.
Job Description
- Overall responsibility for the implementation and maintenance of PV processes/procedures in the cluster countries in line with regulatory requirements and company procedures.
- Act as the National Contact Person for Pharmacovigilance (NCCPV) if required by local legislation, and/or LSO on the relevant Cluster Countries
- Implement and maintain PV processes and procedures in alignment with regulatory and internal standards.
- Ensure timely and complete responses to Health Authority (HA) safety requirements.
- Monitor regulatory changes and assess impact on PV systems.
- Lead inspection readiness locally in close cooperation with global/regional teams and act as SME during audits and inspections in the designated countries.
- Oversee the performance of PV activities in line with the defined KPIs, implementation of all necessary CAPAs and process improvements
- Report performance metrics and deviations to DS Global.
- Oversight of PV vendors, their qualification and training (as applicable).
- Coordinate and maintain backup arrangements to ensure PV operational continuity.
- Create and update local procedures based on regulatory requirements and global processes.
- Maintain and regularly update local Standard Operating Procedures (SOPs) to ensure alignment with current regulatory requirements and global PV processes.
- Prepare and implement PV agreements with license partners and PV service providers.
- Ensure PV clauses in locally organized data collection project (ODCP) contracts clearly define adverse event collection and that the process is effectively executed.
- Oversee collection, reconciliation, and submission of safety reports for both of ICSR and Aggregate report.
- Review local scientific literature for adverse drug reactions (ADRs) and potential safety signals.
- Develop and deliver PV training to affiliate staff and vendors.
- Locally implement Risk Management Plans (RMPs). additional risk minimization measures and safety communications, ensuring translation, regulatory negotiation, and effective execution.
- Collaborate with local cross-functional teams to ensure PV compliance in affiliate activities. (e.g. Support local non-interventional studies and ODCP (Organized Data Collection Program), local affiliates sponsored digital initiatives including company websites).
- Ensure business continuity and crisis response systems are in place.
Job Requirement
• Bachelor's degree in life science, pharmacy, or medical sciences at minimum; 6-9 years of PV experience with an advanced degree; 8-11 years of PV experience with a bachelor's degree.
• Proficient in English; fluent in at least one of the local languages is preferred.
• Proficiency in multiple local languages is a plus.
• Extensive knowledge of local, and international PV regulations.
• Demonstrated leadership and operational experience in matrix organizations, including people management and cross-functional collaboration.
• Experience in regulatory authority engagement.
• High reliability and accuracy in operations.
• Analytical and systematic problem-solving approach.
• Strong communication skills and cultural adaptability.
• Proactive, autonomous, and dependable work style.

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