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Global Technical Recruiter Hiring Top Talent for Innovative Biotech/Medtech/Pharma Companies
Position: Pharmacovigilance Manager
Our client, a Biopharma company, seeks a pharmacovigilance (PV) expert responsible for all associated PV activities and deliverables in clinical development, working with all internal functions and oversight of vendors. This is a full-time permanent hybrid role, requiring presence in the Dublin office some days per week.
The successful candidate will take a leadership role for all aspects of PV, including signal detection, safety and benefit-risk evaluations, management of potential safety issues, evaluation of databases for safety signals, and drafting responses to regulatory inquiries on product safety issues.
Responsibilities for PV Manager:
1. Ongoing design, implementation, and review of the Pharmacovigilance system ensuring compliance with established requirements.
2. Obtain information for deficiencies and non-compliances within the Pharmacovigilance system.
3. Conduct audits of the PV system and licensing partners in collaboration with the Quality team.
4. Work closely alongside Clinical Development and Clinical Operations teams to monitor emerging safety concerns from ongoing clinical trials.
5. Contribute to and review key trial documents pertaining to safety monitoring, e.g., Safety Management Plan.
6. Collaborate with regulatory affairs to ensure the PV system is implemented in compliance with regulatory requirements across the EU and US.
7. Monitor the quality of third-party PV vendors across development programs.
Requirements for PV Manager:
1. BSc in Pharmacology or similar relevant discipline. Postgraduate qualifications are desirable (e.g., MSc, PhD, PharmD, MD, or equivalent).
2. Depth of Drug Safety operations, Pharmacovigilance, and Project Management experience in clinical trials and drug development processes.
3. Experience in Drug Safety Applications and Regulatory compliance applications is a plus.
4. Knowledge of 21 CFR Part 11 guidelines, EMA GvP modules, and Computer system validation guidelines.
5. Experience in Service Delivery of Drug Safety projects.
6. Proficiency in the use of ARGUS or equivalent Drug Safety Database with strong expertise in Microsoft Office.
For further details, please contact Larry on +353 1 – 2302400 or larry@rftgroup.ie.
The RFT Group, BioPharmaceutical Division specializes exclusively in the recruitment of scientists, engineers, and executives for the biotechnology, pharmaceutical, and medical device sectors. Visit www.rftgroup.ie.
Seniority Level
Mid-Senior level
Employment Type
Full-time
Job Function
Science, Quality Assurance, and Research
Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
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