Pharmacovigilance Specialist Maternity Replacement

This position is accountable for executing the day-to-day operations and compliance activities to maintain high functioning PV systems across assigned region.

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.
• Performs 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.
• Develops and maintains the local PSMF in line with AbbVies PV system master file when required by local/regional regulations.

ICSR Management

• Records processes and conducts follow up and translates adverse events and other safety information from spontaneous and solicited sources.
• Performs ICSR expedited reporting according to the local requirements.
• Ensures local-language medical or scientific literature review.
• Implements an appropriate local quality control (QC) procedure to ensure quality of information entered and reporting decisions.
• Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures.

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.

Qualifications :

• 1 year experience required within the pharmacovigilance or a related field
• Excellent command of written and spoken English; fluency in Romanian is mandatory and proficiency in any additional language is a plus
• 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

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