Job Description

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.

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.