Local Medical Safety Specialist

• Safety management & reporting
• Case processingKey responsibility is to ensure that systems and processes are available for collection (initial and follow-up), review, reporting, and reconciliation of Adverse Events (AEs), Adverse Events combined with Product Quality Complaints (AE+PQCs), and pregnancy reports acquired through various sources, such as spontaneous, solicited, clinical trials, data generating activities, local Regulatory Authorities and more.
• Translations - Translation of ICSRs, PSURs, HA correspondence, and regulatory intelligence, and other PV relevant documents when needed.
• Oversight and providing inputOversight of data-generating activities to ensure any solicitation for information includes an appropriate review and reporting process for reporting potential AEs (e.g. patient support programs, market research surveys, internet sites), as applicable.
• Assure that all vendor contracts have appropriate Pharmacovigilance language incorporated and that these contracts are archived in the global system, as applicable.
• Safety oversight of clinical projects conducted in the territory as applicable.
• Clinical activities complianceCollaboration with Medical Affairs for the review and approval of safety aspects of local study protocols or Patient Support Programs (PSP) to ensure appropriate safety reporting to Global Medical Saftey or appropriate case management centre and RA, as required.
• Submission to RA
• Maintain overall responsibility for the coordination of safety requirements as delegated by Marketing Authorization Holders (MAH).
• Aggregate reporting - Plan and ensure timely submission of Aggregate Reports according to local regulations.
• Literature search - Identify local Medical/Scientific Literature not available to our global teams, review for AEs, and report as required per literature reporting criteria.
• Business Continuity - Creation and implementation of business continuity plans (e.g. inspection readiness, AE reporting coverage).
• Risk Management - The Local Safety Officer should have an appropriate system of PV and Risk Management in place in order to assure appropriate oversight for the implementation of Risk Management Activities for products within its responsibility.
• New Safety Information - Take appropriate measures to ensure that new safety information is available to Health Care Providers in a timely manner, if applicable.
• Pharmacovigilance service provision
• Agreements / Contracts Management - Perform contract review and maintain oversight to ensure safety reporting obligations are defined and integrated into case handling procedures as necessary.
• Inspection preparation & support - Ensure PV inspection readiness on the LOC level at all times.
• Processes & regulations
• Procedural Document design - Ensure implementation of Global and Local Procedural Documents and/or write, validate and implement the Local Implementation Documents (LID) for Regional / Local Medical Safety Standard Operating Procedures/Working Practices and verify adherence.
• Safety Policy and Strategy
• Ensure awareness of changes in regulations that may impact PV activities and responsibilities. Evaluate the impact on local processes.