Deputy QPPV
- Employer
- Thornshaw Recruitment
- Location
- Dublin (City), Leinster (IE)
- Salary
- Negotiable
- Start date
- 5 May 2021
- Closing date
- 4 Jun 2021
View more
- Discipline
- Clinical Research, Drug Safety, Pharmacovigilance
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
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.
Pharmacovigilance-QPPV
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)
Medical Information
- 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 further details contact Tina at +353 1 2784701 or email your CV to tdunne@thornshaw.com
Thornshaw scientific is a division of the CPL group www.thornshaw.com
Company
Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment. In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.
Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.
Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.
Our Industries
We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years.
Our Specialities
Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.
Our Mission
For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com
- Website
- http://www.thornshaw.com/
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