Pharmacovigilance (PV) Manager (Regional)

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.