(Senior) Pharmacovigilance Specialist (maternity cover)

This position is accountable for executing the day-to-day operations and compliance activities to maintain high-functioning PV systems across assigned region remit. Reports directly to PV Operational Team Lead OR Regional PV Lead. 

Responsibilities

• Metrics and Oversight of the Pharmacovigilance System

  Supports 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 and internal company timelines/standards.

• Quality Management System

  Develops and maintains local/regional procedures in line with corporate procedures and local requirements.

• ICSR Management

  Records processes and conducts follow up and translates adverse events and other safety information from spontaneous and solicited sources.

• Periodic Safety Reporting

  Leads the preparation of periodic safety reports (e.g. PSUR). local annexes local variations and translation of safety deliverable documents. Ensures submission of periodic safety reports and ensures documentation of evidence.

• Audits and Inspection Management

  Actively assists in managing internal PV audits audits of affiliate service providers/third parties and Regulatory Authority PV Inspections. Actively assists in 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 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 

  Monitors local (and applicable regional/area) PV-relevant hard intelligence leading the impact assessment of them.

• Risk Management

• Safety Monitoring

• After Hours Availability & Business Continuity

Qualifications :

• A minimum of 2 years experience required within the pharmacovigilance or a related field for Senior role
• Effective communicator and able to work effectively in teams and a cross functional environment.
• Strong commitment to compliance with relevant rules and procedures.
• Effective planning and organizational skills and the ability to complete activities with high quality.
• Excellent command of English language

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 :

No

Employment Type :

Full-time