Associate Director of Safety Physician

Highly Competitive
  1. Permanent
  2. PV Physician
  3. Germany
Frankfurt am Main, Germany
Posting date: 28 May 2020
This vacancy has now expired

A global pharmaceutical organisation is recruiting for an Associate Director of Safety Physician to join their team in Germany. If you're looking for a change a pace, join this revolutionary ream and help change the face of medicine.

Job Responsibilities

  • Participating in the conduct of pharmacovigilance for assigned products or projects including medical assessments, on-going safety evaluation, signal detection and benefit-risk assessments
  • Interacting with EMA, NCAs, Region Europe Affiliates, partners and service providers
  • Contributing to and reviewing key Pharmacovigilance documents such as Risk Management Plans, safety sections and other labelling documents.
  • Provides expert knowledge to ensure that the documents meet the regulatory requirements.
  • Participates in NDA/MAA filings, health authority interactions, and FDA Advisory Committee meetings, as applicable
  • Training of company personnel, Contract Research Organisations, and investigational site personnel regarding Pharmacovigilance related issues

Skills and Requirements

  • University degree in Medicine (Medical Doctor)
  • At least 2 years experience as a safety/PV professional, preferably in a global role
  • Experience in interacting with global regulatory authorities
  • Strong knowledge of EU Pharmacovigilance legislation, including GVP, and familiar with international regulations such as US FDA regulations,
  • Excellent written and oral communication skills in English
  • Good understanding of clinical practice in Europe. Experience with patient care in Europe preferred
  • Good presentation skills

To Apply

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A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.