PV Operational Team Lead

This position is accountable for executing the day-to-day operations and compliance activities by leading a team of PV operational associates to maintain high-functioning 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 as per country attestation form:

1. Maintains oversight of AbbVies PV system master file (PSMF) with the authority to ensurethat the information contained is an accurate and up-to-date reflection of the PV system.
2.  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:

1. Recording processing and conducting follow up and translation of adverse events and other safety information from spontaneous and solicited sources.
2. ICSR expedited reporting according to the local requirements. local-language medical or scientific literature review. appropriate local quality control (QC) procedure to ensure quality of information entered and reporting decisions.
3. 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) PV-relevant hard intelligence leading the impact assessment of them.

Team Lead

• Provides strategic and operational leadership to ensure high performing Regional PV systems under their responsibility (coverage up to 3 Affiliates)
• Leads recruitment on-boarding training development through coach and mentoring performance management and succession planning of appropriately skilled staff (team size up to 8-10 PV Regional staff).

Qualifications :

• Faculty of Medicine Dentistry or Pharmacy
• A minimum of 4-6years experience required within the pharmacovigilance or a related field including experience in overseeing PV operational and compliance metrics
• A minimum of 2-3 years people management experience for medium-large sized teams
• Local language is required; Bulgarian or Slovenian language capabilities are nice to have
• 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

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