Deputy QPPV

Location
Dublin (City), Leinster (IE)
Salary
Negotiable
Posted
05 May 2021
Closes
04 Jun 2021
Ref
JO-2104-466905
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

    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