Job Description
The RFT Group, Biopharma & Medtech Recruitment, 10,Glengarriff, Rochestown Ave., Dunlaoghaire,
Co. Dublin. A96 W654. Ireland. Phone: + 353 (0) 1 2302400 Email: larry@rftgroup.ie Web: www.rftgroup.ie
Pharmacovigilance Manager
Our client, a Biopharma company, now seek a pharmacovigilance (PV) expert who will be 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 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 of responses to regulatory inquiries on product safety issues.
The ideal candidate will be a PV expert with depth of experienced in Drug Safety Operations and Pharmacovigilance within a fast-paced Pharma / Biopharma environment.
Responsibilities for PV Manager:
Ongoing design, implementation and review of the Pharmacovigilance system ensuring it is implemented in compliance with established requirements.
Obtain information for deficiencies and non-compliances within the Pharmacovigilance system.
Conduct audit of the PV system and licensing partners in collaboration with the Quality team.
Work closely alongside Clinical Development and Clinical Operations teams to monitor emerging safety concerns from ongoing clinical trials.
Contribute to and review key trial documents pertaining to safety monitoring e.g. Safety Management Plan
Work closely with regulatory affairs to ensure the PV system is implemented in compliance with regulatory requirements across the EU and US.
Work collaboratively with and monitor the quality of third-party PV vendors across development programs:
Requirements for PV Manager:
BSc in Pharmacology or similar relevant discipline. Post graduate qualifications are desirable (e.g. MSc, PhD, PharmD, MD, or equivalent).
Depth of Drug Safety operations, Pharmacovigilance and Project Management experience in clinical trials and drug development process.
Experience in Drug Safety Applications and Regulatory compliance applications a plus.
Knowledge of 21 CFR Part 11 guidelines, EMA GvP modules, Computer system validation guidelines.
Experience in Service Delivery of Drug Safety projects.
Proficiency in use of ARGUS or equivalent Drug Safety Database with strong expertise in Microsoft office.
For further details, please contact Larry on +353 1 – 2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie