Country Safety Lead – International Pharmacovigilance

Job Purpose and Scope:
Fulfil the responsibility for the coordination and execution of all Pharmacovigilance (PV) activities across the Pharmaceutical and Consumer sector to ensure that all of Johnson & Johnson’s statutory and ethical responsibilities are met. Act as the Local Operating Company (LOC)’s and assigned territories’ (as applicable) main contact point for PV matters with the local Health Authority, Global Medical Organisation (GMO), Global Medical Safety (GMS) and Office of Consumer Medical Safety (OCMS). Provide strategic leadership and support LOC to meet all global and local PV responsibilities
Core Job Responsibilities:
Oversight of the PV System –
• Oversight of the full cross sector product portfolio, and link with local management and key stakeholders
• Maintain oversight of all required PV regulatory reporting compliance in a timely manner.
• Advise the business on the PV impact of local organized data collection programs.
• 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.
• Provide high quality and consistent input to development of local safety initiatives and programs.
• Plan and deploy skilled resources against project priorities, if applicable
• Maintain an environment of continuous improvement within the PV team and contribute to continuous improvement initiatives across the region and globally with GMO, GMS and OCMS.
Case processing & HA reporting –
• Ensure that local processes, procedures and systems are in place for tracking, processing, and conducting follow up for Adverse Events (AE) and other safety information reportable to GMS and OCMS from spontaneous, and solicited sources.
• Ensure comprehensive data collection and follow-up to obtain additional information relevant to the case as necessary to provide a complete description of the safety event.
• Ensure local medical or scientific literature, not included in global literature review, are reviewed to identify possible adverse events or special situations reportable to GMS and OCMS, and that any reports are forwarded in a timely manner to GMS and OCMS.
• Implement an appropriate local quality control (QC) procedure to ensure quality of information entered in cases sent to GMS and OCMS and of reporting decisions to local Health Authority.
• Ensure a local process is in place for periodic quality control (QC) sampling of records without AEs for AE identification as applicable (e.g. product quality complaints (AEPQCs), medical enquiries, partner / vendors etc.).
• Ensure that patient confidentiality and privacy in accordance with local applicable laws and regulations are adhered to and if necessary, performed by redaction of patient information.
• Ensure a local process is in place to forward AEPQCs to Business Quality (BQ) within 24 hours of receipt by PV.
• Ensure AEPQCs are reviewed for AEs, complete AE reconciliation and ensure any AEPQCs identified are forwarded to BQ
Compliance –
• Ensure compliance with the CAPA process for the reporting and investigation of exceptions (nonconformance, potential nonconformance and planned deviations).
• Ensure a local tracking system is in place to ensure timely submissions of adverse events (AEs) to GMS.
• Ensure reporting of both clinical and post-marketing individual case safety reports (ICSRs) and periodic reports to the regulatory authority as required (and ethics committee, if applicable).
• Report monthly compliance metrics and information to QPPV Office, GMS, International PV, Compliance, Strategy and Analytics (CSA), and BQ within the required timelines
• Maintain awareness of local post-marketing and clinical PV legislation and guidelines
• Ensure Line Manager/APAC Cross Sector Safety Lead, and PV Policy Group are promptly notified of any changes to relevant local legislation.
• Ensure formal documentation and notification to PV Policy Group of local reporting requirements for both ICSRs and aggregate reports, provide updates to these requirements per changes in local legislation, and review and confirm these requirements at least annually.
• Coordinate affiliate review and submission of PSURs & DSURs.
• Ensure any changes to affiliate safety personnel are communicated to the Health Authority (i.e. nominated contact person for PV), GMS, OCMS and IPV in a timely fashion.
• Complete AE reconciliation with interacting departments and/or partner companies (if applicable) and act upon any discrepancies
• Review and confirms regulatory reporting requirements at least bi-annually
Collaborate & Support
• Collaborate with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local RA to the appropriate global and regional groups as appropriate. Collaborate with appropriate departments to identify the resources and expertise needed to address the question. This may include local, regional and/or global expertise.
• Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols to ensure appropriate safety reporting to GMS or appropriate case management centre and Health Authority, as required.
• Where applicable, support the Qualified Person Pharmacovigilance (QPPV) to provide safety-related regulatory communication (e.g., response to request for information from local Health Authority, including the provision of information about the volume of sales or prescription, as appropriate.
• Participate in the Product Issue Management teams, as appropriate.
• Provide technical and strategic input and participate in projects led by the regional GMS team and GMS work streams.

- Attractive Salary