Area Safety Team Lead, South East Asia

The Area Safety Team Lead, South East Asia (SEA), is the safety leader for Pharma and Consumer products for the South East Asia region, including Malaysia & Brunei, Indonesia, Philippines, Singapore, Thailand & LCM, and Vietnam.

The Area Safety Team Lead, SEA will report to the Asia Pacific Cross-Sector Safety Head, International Pharmacovigilance. He/she will:

- Ensure that the Local Operating Company (LOC) SEA region safety activities related to medicinal and non-medicinal products are managed in compliance with local regulations and company policies/procedures at a local, regional and global levels and in accordance with any Product vigilance agreements with third party business partners.
- Have appropriate Pharmaco
- and consumer product vigilance, risk management systems and adequate record management in place in order to assure appropriate oversight for products within its responsibility.
- Manage Local Medical Safety activities to:

- Ensure the pro-active Benefit Risk Management throughout product life cycle translating global safety data to insights and actions tailoring to local specificities and needs
- Support activities related to safety reporting requirements as required by Marketing Authorization Holders (MAH) and/or study sponsor, as applicable
- Act as the Local Operating Company (LOC)’s and assigned territories’ (as applicable) main contact point for Pharmaco
- and consumer product vigilance matters with the local Health Authority, Global Medical Organization (GMO), Global Medical Safety (GMS), and Office of Consumer Medical Safety (OCMS).
- Provide strategic leadership and support LOC to meet all global, regional, and local pharmacovigilance (PV) responsibilities.
- Participate in (and may lead) International Pharmacovigilance (IPV) regional and global projects and initiatives.
- Serve as a member of the Asia Pacific (APAC) IPV Leadership Team.

PRINCIPLE RESPONSIBILITIES
- Oversight of the PV System & Overall Responsibilities:

- Maintain oversight of the full cross sector product portfolio and all required PV regulatory reporting compliance in a timely manner.
- Support Country Safety Team Leads (CSTLs) with the local MAH activities to enable fulfilment of its regulatory responsibilities and meet business objectives
- Monitor and forecast PV workload to identify, mitigate and escalate potential PV resource and non-compliance issues
- Support and lead process improvements to optimize the PV system and make best use of PV resource
- Work collaboratively with regional affiliates to ensure consistency of approach across groups
- Build and maintain effective business relationships across the LOC to support the implementation of safety standards
- Ensure local Pharmacovigilance System Master File (PSMF) implementation and maintenance by the CSTL and provide regional oversight
- Collaborate with local/cluster Case Management team to ensure LOC/Local Safety Unit (LSU) audit and inspection readiness at all times
- Safety Management & Reporting:

- Ensure that local processes, procedures and systems are in place for collection (initial and follow-up), review, tracking, processing, reporting, reconciliation and follow up of Adverse Events (AE), Adverse Events combined with Product Quality Complaints (AE+PQCs), pregnancy, all other special situation reports and any other safety information reportable to GMS and OCMS from any sources
- Maintain oversight on inbound and outbound reporting via the CSTL and appropriately resolve or escalate any compliance or quality issues
- Establish adequate collaboration with Regional Case Management Lead to maintain regional compliance oversight on case processing, follow up requests, reconciliation, local medical or scientific literature search, which are not included in global literature review, and submission to local HA
- Ensure in collaboration with Case Management team translation of Individual Case Safety Reports (ICSRs), Periodic Benefit Risk Evaluation Reports (PBRERs)/Periodic Safety Update Reports (PSURs), HA correspondence, regulatory intelligence, as required
- Collaborate with Regional Case Management Lead to ensure adequate oversight of Aggregate Report activities for LOCs of responsibility
- Provide regional support and oversight for all RRAs in LOCs of responsibility to ensure adequate review and AE reporting processes are in place
- Local Medical Safety Management Activities:

- Support the Local Medical Safety teams to establish Product knowledge with focus on safety profiles, Therapeutic Area and Disease Pathway knowledge supporting the needs of the local Medical Affairs and Marketing organization in collaboration with the International Medical Safety leader
- Act as safety expert in cross-functional team meetings and perform training on safety relevant aspects, as appropriate
- Ensure oversight of Risk Management Plan (RMP) activities in LOCs of responsibility including support in the pre-submission, submission and post-marketing product