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Drug Safety Physician - Global Pharma

Employer
Barrington James
Location
Germany (DE)
Salary
Comprehensive Package
Start date
16 Sep 2021
Closing date
16 Oct 2021

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Job Details

My client a leading Pharmaceutical Company are currently looking for an experienced Pharmacovigilance Physician to join their diverse, collaborative and inclusive Safety Team. You will be integral in the continued establishment and development of the safety function of the business as they continue to grow. You will lead safety profile oversight for all assigned products, across their full life cycle whilst working cross functionally to ensure the needs of this dynamic and fast-moving business are met. This is a position with both a hands on and a strategic focus. If you are an experienced Pharmacovigilance Physician, please read below…

Responsibilities;

  • Performance of medical review of AE’s for assigned products alongside ongoing surveillance of safety data from various sources
  • Implementation of risk mitigation activities, preparation of benefit/risk sections of aggregate reports and safety summaries in accordance with regulatory requirements for assigned compounds
  • Performance of medical review and provide safety input to for various documents e.g. trial protocols and amendments, clinical trial reports, trial plans, eCRFs/CRFs, TMFs,IBs, Subject Informed Consent, DSURs, Integrated Safety Summaries, scientific articles, etc.
  • Active involvement in for establishing and managing external data monitoring
  • committees (DMCs)
  • Participate and/or run safety committees for assigned products
  • Conduct safety training of colleagues, CROs and investigators
  • Contribute to multidisciplinary project groups and provide input to clinical development programs
  • Performance of sponsor oversight, collaborate with external experts and partners, contribute to multidisciplinary project groups
  • Ensure compliance with regulatory guidelines and internal procedures in order to be prepared for audits and inspections, participate in audit and inspection activities as relevant

Requirements;

  • Medical Degree (MD) required
  • Excellent understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP).
  • Exposure to working relationship with EMA/Swissmedic/MHRA and other regulatory authorities (FDA) is preferred
  • Strong knowledge of individual adverse event case report processing, triage and medical review
  • Working knowledge of safety databases and electronic data capture systems
  • Working experience with PV audit process with active participation in Regulatory Authority Inspections
  • Excellent knowledge of drug development process
  • Excellent written and oral communication skills

 

 

Following your application Daniel Hockaday, a specialist Pharmaceutical Recruiter with 4 years’ experience as a specialist recruitment Consultant will discuss the opportunity with you in detail. He will be more than happy to answer any questions relating to the industry and the potential for your career growth. The conversation can also progress further to discussing other opportunities, which are also available right now or will be imminently becoming available.

This position will be very competitive, and it is likely that it will close prematurely. We recommend applying as soon as possible to avoid disappointment. Please click ‘apply’ or contact with Daniel Hockaday for any further information.

Daniel .C. Hockaday

Pharmacovigilance, Drug Safety & Medical Safety Surveillance Lead

Email: Dhockaday (at) barringtonjames.com

Company

We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.

Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.

Company info
Website
Telephone
01293 776644
Location
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB

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