Affiliate Safety Representative
Affiliate Safety Representative
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
We are seeking an Affiliate Safety Representative to join our Citywest office in Dublin. In this role you will lead the coordination and implementation of all pharmacovigilance activities ensuring that AbbVies legal and ethical obligations are fulfilled. You will serve as the primary contact for the Affiliate on pharmacovigilance matters liaising with the National Regulatory Agency and AbbVies Pharmacovigilance and Patient Safety (PPS) function. This position provides strategic leadership for managing and supporting the pharmacovigilance team in carrying out their duties. It reports directly to the Affiliate Medical Director with an additional indirect reporting line to the EU Qualified Person for Pharmacovigilance (QPPV) for all PVrelated issues.
Responsibilities:
- Foster effective business relationships across the affiliate to implement patient safety standards.
- Enhance PV systems through continuous improvement and collaboration with PPS experts.
- Support recruitment training coaching and performance management of PV staff.
- Monitor affiliate PV compliance workload and resource management.
- Address compliance issues and ensure PV processes for digital media and internet safety data.
- Ensure local SDEAs meet AbbVie procedures and local requirements; manage inventory in PPS PV Agreements Database.
- Maintain compliance with local agreements.
- Serve as key contact for internal PV audits and regulatory inspections.
- Ensure timely audit responses and corrective actions; support vendor audits and corrective plans.
- Collaborate with Affiliate Risk Management Team to review RMPs and implement risk minimization measures.
- Develop and revise Local RMPs with ARMT & Benefit Risk Management Team.
- Monitor medicinal product safety profiles and emergent concerns.
- Communicate safety data changes to PPS Product Safety Team Lead and EU QPPV.
- Establish afterhours reporting and disaster recovery plans for critical PV processes.
- Strengthen relationships with affiliate colleagues and enhance understanding of PV requirements.
Qualifications :
- Degree in medical pharmacy or life sciences (or equivalent).
- Minimum of 25 years in a pharmacovigilance role within the pharmaceutical industry is required; experience managing direct reports is preferred.
- Excellent written and verbal communication and presentation skills.
- Fluency in written and spoken English is essential for communication with Pharmacovigilance and Patient Safety Area/Regional Medical and other headquarters functions. Fluency in the local language is required for interactions within the affiliate medical department and with the National Regulatory Agency.
- High focus on customer service.
- Strong commitment to adhering to all relevant regulations and guidelines.
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:
No
Employment Type :
Fulltime
Employment Type
Full-time
