Local Medical Safety Specialist

Local Medical Safety Specialist, Indonesia

Local Medical Safety Specialist, Indonesia, is the safety specialist responsible for Johnson & Johnson products for Indonesia.

He/she Will Work With The Country Safety Lead, Indonesia, To

The Local Medical Safety Specialist, Indonesia will report to the Cluster Safety Lead, Malaysia, Brunei and Indonesia within the International Pharmacovigilance (IPV) organization.

• Have appropriate Pharmacovigilance, risk management systems and adequate record management in place in order to assure appropriate oversight for products within its responsibility.
• 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.

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.

• Management of local PVAs and ensure local implementation, including LSU training and adherence to PVAs.
• Maintain oversight on day-to-day adverse event (AE) inbound and outbound reporting as applicable.
• Ensure that a process is in place for reporting of AEs after hours, and testing is documented as per Global and Regional requirements. In collaboration with Case Management team, ensure that a disaster recovery/business continuity plan (BCP) is established in a risk-based manner to allow for continuation of critical business processes for PV, e.g. inspection readiness, AE reporting coverage and etc.
• 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.
• 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.
• 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 Management System. Perform PV training to maintain of awareness of drug safety reporting in general for LOC employees, as required; and ensure proper documented training. Manage AE/PQC trainings for distributors/vendors and translation of AE/PQC training material, where needed.
• 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.
• Perform medical safety review of individual cases from global safety database (when requested) and medical input and insights for aggregate reports
• Act as the local PV contact person for all PV audits and inspection and coordinate the audit and inspection preparations for internal PV audits (e.g. Bioresearch, Quality & Compliance (BRQC)) and external PV inspections. Assist inspectors/auditors; support document requests in collaboration with relevant stakeholders. Address follow-up actions from findings and ensure that any HA communications are forwarded to the required PV personnel and that any responses/corrective actions are tracked and completed according to schedule.
• Provide Risk Management Plan (RMP) status updates, and prepare local RMPs/Addendums, etc, as applicable.; be involved in local safety signal detection, as applicable.
• Act as safety expert in cross-functional team meetings and perform training on safety relevant aspects, as appropriate.
• Safety Management & Reporting:
• 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)
• 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.
• 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.
• Act as Locally Nominated Back-up Person for Pharmacovigilance
• Involvement in DHPCs management, submit and track DHPCs to HAs/HCPs, as applicable.
• Local Medical Safety Management Activities:
• 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.
• 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.
• 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.
• Conduct safety policy and strategy, including monitoring and implementing PV regulations and shaping regulatory environment.
• 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.
• Participate in meetings with relevant stakeholders for discussion and evaluation of topics related to benefit risk and product safety.

Primary Location

Asia Pacific-Indonesia-Jawa-Jakarta Raya

Organization

J&J Indonesia NewCo

Job Function

Drug & Product Safety Operations

Job Qualifications

• Bachelor’s degree in the field of Medical, Life Sciences, Pharmacy or related
• 1 to 3 years of work experience

Experience

• Scientific study and experience in pharmaceutical regulations and R&D processes.
• Pharmaceutical industry experience including a PV responsibility role required.

Essential Knowledge & Skills

• Sound knowledge of general medicine or pharmacy and clinical practice, scientific/life-science background, medicinal knowledge preferred; proficiency in Medical terminology.
• Proven ability to organize workflow activities and manage multiple critical issues.
• Computer literate with basic knowledge of safety database systems.
• Good verbal and written communication skills, fluency in English required.
• Awareness of and familiarity with industry principles of drug development and pharmacology.
• Ability to negotiate and communicate with internal and external stakeholders. Ability to establish and maintain open relationships within the organisation and with authorities.
• Demonstrable knowledge of all local PV requirements and of Global aspects of drug safety.