Country Safety Lead, Indonesia
5 days ago
Country Safety Lead, Indonesia is the safety leader responsible for Johnson & Johnson products for Indonesia.
The Country Safety Lead, Indonesia will report to the Cluster Safety Lead, Malaysia, Brunei and Indonesia, within the International Pharmacovigilance organization. He/she will:
- Ensure that the Local Operating Company (LOC) safety activities in Indonesia, related to medicinal products are managed in compliance with local regulations and company policies/procedures at local, regional and global levels and in accordance with any Product vigilance agreements with third party business partners.
- Have appropriate Pharmacovigilance, 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.
**PRINCIPLE RESPONSIBILITIES**
- **Act as Local Nominated Person**
- Act as locally nominated person for Pharmacovigilance (PV) assuming the PV role as defined by national law/regulation. Collaborate with the Qualified Person for Pharmacovigilance (QPPV) offices as required.
- **Oversight of the PV System & Overall Responsibilities**:
- Maintain oversight of the full product portfolio and all required PV regulatory reporting compliance in a timely manner.
- Ensure that day-to-day PV functions are performed satisfactorily, and that full regulatory compliance is maintained at LOC level including adequate record management.
- Collaborate with the local MAH to enable fulfilment of its regulatory responsibilities (including Pharmacovigilance Agreement [PVA]) and meet business objectives
- Escalate compliance issues in a timely manner to Line Manager and Area Safety Team Lead, SEA to ensure appropriate mitigation is implemented.
- 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- Oversight and maintain the International PV (IPV) Pharmacovigilance System Master File (PSMF) and responsible for the local PSMF implementation and maintenance, as applicable.- 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 end-to end adverse events, adverse events with product quality complaints, and special situation reports management.
- Maintain oversight on day-to-day AE inbound and outbound reporting as applicable.
- Accountable for ensuring that the LOC meets procedurally defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.
- In collaboration with Case Management team, conduct case processing, follow up requests, reconciliation, local medical or scientific literature search, which are not included in global literature review, translation of ICSRs, HA correspondence, regulatory intelligence and submission to local HA.
- When applicable, for “Products for Local Opportunity” (POLOs), when GMS does not provide the Aggregate Reports, ensure the specific reports (e.g. PSUR) are prepared if not already provided by a third party under a PV agreement.
- Oversight of data generating activities to ensure appropriate review and reporting process are included in project documents for reporting potential AEs (e.g. patient support programs, market research surveys, internet sites), as applicable.
- **Local Medical Safety Management Activities**:
- 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.
- Provide Risk Management Plan (RMP) status updates, and prepare local RMPs/Addendums, etc, as applicable.; be involved in local safety signal detection, as applicable.
- Participate in meetings with relevant stakeholders for discussion and evaluation of topics related to benefit risk and product safety.
- Take appropriate measures to ensure that new safety information is available to HA and Healthcare Professionals (HCPs) in a timely
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