Job Description
Our client, an international pharmaceutical company based in Dublin, now seeks an experienced Pharmacoviligance Specialist to assist the QPPV in maintaining the Pharmacovigilance systems in line with the requirements for pharmaceutical products globally. This role will have office presence in Dublin, however there is also flexibility to work from home some days per week.
The successful candidate will assist the QPPV in maintaining an overview of the safety profiles of the company’s medicinal products and any emerging safety concerns. In the absence of the QPPV, this hire will act as the single point of contact for PV on a 24-hour basis in the EEA for Competent Authorities for PV related matters.
The ideal candidate will be an experienced QPPV, who has extensive knowledge in Pharmacovigilance (PV) and the requirements of GVP and volume 9B; and experienced in liaising with other departments such as medical information, regulatory, quality and contractors where there are links to PV activities.
Responsibilities for Deputy QPPV:
Respond to requests for information from the Competent Authorities relating to the safety profile of the company products or PV activities
Assist the QPPV in maintaining the Pharmacovigilance System Master File (PSMF) and the Detailed Description of the Pharmacovigilance System (DDPS) for human and veterinary products respectively
Prepare Adverse Drug Reaction (ADR) reports and expedite reports to Competent Authority when required
Conduct periodic ICSR reconciliation with business partners
Generation and management of aggregate reports such as line listings and summary tabulations
Signal management activities including signal detection and validation
Compile and present signal detection and periodic PV reports
Monitor literature searches and maintain the literature monitoring tracking system
Prepare annual schedule for Periodic Safety Update Reports (PSURs)
Prepare, review and assist in submission of PSURs
Prepare, review and submit Risk Management Plans
Prepare and maintain Safety Data Exchange Agreements and Technical Agreements
Monitor compliance metrics and performance of the PV system
Provide PV training to all relevant staff
Take part in all PV inspections and assist in completion of any CAPAs identified
Review and maintain internal and external PV audit schedules
Compile and review all PV Standard Operating Procedures
Ensure appropriate storage and retention of all PV documentation
Receive and process Medical Information enquiries from healthcare professionals and the public
Provide up-to-date and relevant medical and technical information in response to the enquiries
Maintain the medical information trackers for human and veterinary medical products
Requirements for Deputy QPPV:
Bachelor of Science Degree in Biology, Chemistry, Pharmacy or related Life Science discipline.
5 years’ experience in Pharmacovigilance
Previous experience within Medical Information
QPPV or deputy QPPV – registered with the competent authorities
Good judgement and decision-making skills.
Effective oral and written communication skills.
Good interpersonal skills and ability to work in team environment.
Familiar with computers and their applications, e.g. Word, Excel, Power Point.
Please phone Larry on +353 (0)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
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