Pharmacovigilance Team Lead

This position is accountable for executing the daytoday operations and compliance activities by leading a team of PV operational associates to maintain highfunctioning PV systems across assigned region remit. Reports directly to Regional PV Lead

Responsibilities:

Metrics and Oversight of the Pharmacovigilance System

• Coordinates the provision of metrics that will ensure oversight of all aspects of the performance and functioning of the PV system in compliance with local regulations internal company timelines/standards.
• For individuals acting as National QPPV / back up National QPPV:
  • Maintains oversight of AbbVies PV system master file (PSMF) with the authority to ensure that the information contained is an accurate and uptodate reflection of the PV system.
  • Delegates specific tasks under supervision and with documentation to appropriately qualified and trained individuals provided that the QPPV maintains system oversight and overview of the safety profiles of all products.

Quality Management System

• Ensures development and maintenance of local/regional procedures in line with corporate procedures and local requirements.
• Ensures the impact assessment of new/updated corporate policies process and procedures. 
• Actively assists with the PV Exception Reporting/CAPA process. 
• Actively assists with the business continuity plan and testing. 
• Ensures the development and maintenance of the local PSMF in line with AbbVies PV system master file when required by local/regional regulations.

ICSR Management

• Ensures ICSR Management process meets all expectations:
  • Recording processing and conducting follow up and translation of adverse events and other safety information from spontaneous and solicited sources.
  • ICSR expedited reporting according to the local requirements.
  • locallanguage medical or scientific literature review.
  • appropriate local quality control (QC) procedure to ensure quality of information entered and reporting decisions.
  • AE reconciliation and AE identification effectiveness sampling consistent with global procedures.

Periodic Safety Reporting

• Coordinates the preparation of periodic safety reports (e.g. PSUR). local annexes local variations and translation of safety deliverable documents within the Regional PV team.
• Ensures submission of periodic safety reports and ensures documentation of evidence.

Audits and Inspection Management 

• Partners with the Regional PV Lead in managing internal PV audits audits of affiliate service providers/third parties and Regulatory Authority PV Inspections. 
• Partners with the Regional PV Lead and coordinates the development of CAPA in response to observations and the tracking actions to completion in a timely manner. 

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

• Ensures all PV requirements are in place for activities where there is a reasonable possibility for the identification and/or handling of safety information in accordance with AbbVie procedures and local requirements.

PV Training 

• Ensures overall training compliance and oversight with corporate procedures and local PV requirements including the maintenance of the PV Training Matrix and the development of additional PV training materials as required.

Legislation Intelligence 

• Coordinates the monitoring of local (and applicable regional/area) PVrelevant hard intelligence leading the impact assessment of them.

Risk Management

• For Individuals supporting Risk Management activities:  
  • Coordinates the receipt and distribution of RMP Core Implementation Plan (CIP) and additional risk minimization measures (aRMM) to Affiliate stakeholders..
  • Develops a deep knowledge of the Risk Management Plans (RMPs) to obtain information on the risk/benefit profile of products.
  • Liaises with Affiliate stakeholders & Benefit Risk Management (BRM) Team and where applicable seek involvement of relevant PSEQ stakeholders during development or revision of the COUNTRY Specific Annex (if applicable) Local Implementation Plan (LIP) & local aRMM.
  • Performs the assessment and implementation of the CIP and accompanying aRMM when applicable

Safety Monitoring

• For Individuals supporting Safety Monitoring activities and/or as National QPPV / back up National QPPV:
• • Understands and monitors incoming local safety data and communicate changes or potential concerns to the PSEQ Product Safety Team Lead and the EU QPPV (for products marketed in the EEA) for evaluation.
  • After Hours Availability & Business Continuity
  • Ensures availability to be at AbbVies disposal permanently and continuously on a 24hour basis if applicable and that an afterhours process is in place for the reporting of AEs and that a Disaster Recovery Plan/Business Continuity Plan is established to allow for continuation of critical business processes for PV.

Team Lead

• Provides strategic leadership to manage and support the Regional PV staff in executing assigned responsibilities. 
• Supports recruitment onboarding training development through coach and mentoring performance management and succession planning of appropriately skilled PV Regional staff. 

Qualifications :

• A minimum of 34 years experience required within the pharmacovigilance or a related field including experience in overseeing PV operational and compliance metrics  
• Effective communicator and able to work effectively in teams and a cross functional environment
• Strong commitment to compliance with relevant rules and procedures
• Sound judgement  planning and organizational skills and the ability to complete activities with high quality. execution of daily tasks and management of responsibilities

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

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