Deputy Affiliate Safety Representative

1 week ago

Bengaluru, Karnataka, India ABBVIE Full time

Job Summary:


To actively support ASR in the coordination and execution of all aspects of pharmacovigilance at the affiliate to ensure that AbbVie's statutory and ethical responsibilities are met.

Act as Back up for Affiliate's main contact point for pharmacovigilance matters with the National Regulatory Agency and AbbVie Pharmacovigilance and Patient Safety (PPS) function

Adverse Event & Periodic Safety Reporting:

  • Triage and process the incoming AE/Safety information. Ensure that processes, procedures, and systems are in place for intake, processing, conducting follow up, translating and reconciling adverse events and other safety information reportable to PPS from spontaneous and solicited sources and from clinical studies.
  • Check for Regulatory reports on every business day to Ensure reporting of both clinical and postmarketing Individual Case Safety Reports (ICSRs) and Periodic and Aggregate Reports to the Regulatory Agency, Ethics Committees, and Investigators, to comply with corporate PV procedures and with local and regional PV regulations as required.

Quality Management System

  • Support ASR in drafting local SOP/Guidance documents.
  • Support ASR to ensure the Affiliate PV System procedure(s) aligns with corporate PV procedures and complies with local and regional PV regulations.
  • Inform ASR on any nonconformity and/or planned departures from corporate and/or local PV procedures according to the global issue and exception management process and ensure any corrective/preventive actions are completed according to the schedule.
  • Oversee training compliance of partner company staff according to local contract requirements. Inform ASR about any deviations.

Partnership with business partner with possibility for identification and/or handling of safety information:

  • Perform assessment of services initiated by partners (Commercial, RA, PR, etc) with the help of global PV partnership guidelines.
  • Partner with Program Owners and commercial leaders to ensure that all business partnerships involving activities where there is a reasonable possibility for the identification and/or handling of safety information are assessed for the generation of safety information and the applicable PV requirements are applied in accordance with AbbVie procedures and local requirements.

Safety Data Exchange Agreements (SDEA) and other PV Agreements:

  • Perform VQA and get it approved by ASR.
  • Draft PVAs, send for review by ASR prior finalization to ensure the content of local SDEAs and other PV agreements conforms to AbbVie procedures and local requirements and maintains the inventory in the PPS PV Agreements Database.
  • Maintain and monitor compliance with local agreements.

Oversight of the Pharmacovigilance System:

  • Provide ASR with the data for monthly metrics which will be filled in DCT.
  • Be informed about maintaining oversight of affiliate PV compliance status and actively monitor PV workload and resources in the absence of ASR.
  • Escalate compliance issues and potential PV resource issues in a timely manner to the ASR to ensure appropriate mitigation.
  • Maintain awareness and monitor local postmarketing and clinical PV legislation, in collaborate with distributors in distributor markets to ensure PV legislation changes are communicated to relevant stakeholders for review, impact assessment, implementation, and mitigation according to global procedures.

Audits and Inspections:

  • Act as the Backup Affiliate contact for both internal PV audits and Regulatory Agency PV inspections.
  • Execute action items assigned by ASR to ensure that any audit/inspection responses/corrective actions are completed according to the schedule.
  • Support local QA and R&D PV QA to conduct vendor audits and complete vendor corrective action plans

Risk Management:

  • Actively assist the ASR in RMP procedures.
  • When nominated, act as a member of the Affiliate Risk Management Team (ARMT), review Risk Management Plans (RMPs) and implement risk minimization measures at the affiliate according to AbbVie procedures and local requirements.
  • Understand the RMPs and information on the benefit/risk profile of products applicable for the Affiliate.
  • When nominated, ensure the appropriate development and revision of Local RMPs and/or Country Specific Annexes, if applicable, liaising with ARMT & Benefit Risk Management (BRM) Team during development and revision of local documents.
  • Act us a Back up to Partner with ARMT & BRM Team during development or revision of the Local Implementation Plan (LIP) & local additional risk minimization measures.

Safety Monitoring:

  • Actively support ASR for maintaining overview of medicinal product safety profiles and any emerging safety concerns for company products marketed within the relevant jurisdiction, and awareness of conditions or obligations adopted as part of the marketing authorizations, commitments relating to safety or the safe use of the products and

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