On behalf of my client, we have a new opportunity for a Deputy QPPV for their Dublin office. This is a full-time permanent role reporting directly to the QPPV based in the UK.
Main Duties and Responsibilities:
- Extensive knowledge in Pharmacovigilance (PV) and the requirements of GVP and volume 9B.
- Assist the QPPV in maintaining the Pharmacovigilance systems in line with the requirements for human and veterinary pharmaceutical products.
- 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, act as the single point of contact for PV on a 24-hour basis in the EEA for Competent Authorities for PV related matters
- 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)
- 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.
Desired Skills and Experience:
- Graduate (or equivalent) in Life sciences in a relevant area (ideally 2:1 or above)
- 5 years’ experience in Pharmacovigilance
- Previous experience within Medical Information
- QPPV or deputy QPPV – registered with the competent authorities.
- Demonstrated planning and organisation skills.
- Ability to work autonomously, effectively, and collaboratively.
- Excellent interpersonal and negotiation skills (internal/external)
For a detailed job spec and discussion please email your CV to [email protected] or call Tina at 087 6811990 or +353 1 2784671.
Thornshaw Scientific is a division of the CPL group.