**Local Medical Safety Specialist, Indonesia**
Local Medical Safety Specialist, Indonesia, is the safety specialist responsible for Johnson & Johnson products for Indonesia.
The Local Medical Safety Specialist, Indonesia will report to the Cluster Safety Lead, Malaysia, Brunei and Indonesia within the International Pharmacovigilance (IPV) organization. He/she will work with the Country Safety Lead, Indonesia, to:
- 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 Locally Nominated Back-up Person for Pharmacovigilance**
- Act as locally nominated back-up 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.
- **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 adverse event (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 Individual Case Safety Reports (ICSRs), HA correspondence, regulatory intelligence, and submission to local Health Authority (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 manner, i.e. Direct Healthcare Professional Communication (DHPC), company core datasheet (CCDS) implementation into local label, USR if applicable.
- Involvement in DHPCs management, submit and track DHPCs to HAs/HCPs, as applicable.
- Provide input into safety sections of local protocols (including Clinical Trials, Non-Interventional Studies, Research Related Activities, Patient Support Programs etc.) to ensure appropriate safety reporting as required by regulations.
- Perform medical safety review of individual cases from global safety database (when requested) and medical input and insights for aggregate reports
- Ensure implementation of all PV relevant Procedural Documents as applicable and/or write, validate and implement the Local Implementation Documents (LID) for Regional / IPV Standard Operating Procedures (SOPs)/Working Practices and verify adherence. Where appropriate develop local controlled procedures to cover local aspects of PV activities.
- Maintain training matrix/plan for local PV personnel which includes, but is not limited to, local SOPs, local regulations and references to the global affiliate PV courses allocated in Learning Managem