Drug Safety Manager

Location
France (FR)
Salary
Comprehensive Package
Posted
06 Jan 2021
Closes
05 Feb 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Senior Drug Safety Manager

My client a leading clinical stage Pharmaceutical business are looking for a Pharmacovigilance / Drug Saftey Manager to join their Pharmacovigilance team. The Pharmacovigilance Manager reports directly in to the Global Head of Pharmacovigilance and will have a huge impact on the development of the business moving forward. If you are, a PharmD or MD with strong Pharmacovigilance experience please read below…

Responsibilities;

  • Responsible for the preparation of the Investigator Brochure, Marketing Authorization dossiers, IND, NDA, Scientific Advice
  • Preparation and review of IDSURs, PSURs, PDERs and pharmacovigilance reports
  • Assess the risk / benefit of the products in all indications
  • Implement and monitor the set-up of pharmacovigilance procedures
  • Ensure compliance of the Pharmacovigilance system in line with regulations
  • Save the reported cases and all pharmacovigilance information in the database
  • Analysis of reported cases with the investigator as necessary
  • Manage the daily activities of the Pharmacovigilance team

Requirements;

  • PharmaD or MD
  • Minimum of 5 years within Pharmacovigilance in a global position
  • Experience Writing product safety and study documents, composition of regulatory dossiers
  • A specialization in oncology and / or autoimmune diseases would be a plus
  • Fluent in French and English

If you are interested, get in touch with me ASAP…

Dan Hockaday

Pharmacovigilance & Drug Safety Recruitment Consultant

Email: Dhockaday (at) barringtonjames.com

Phone: 00441293776644

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