Global Safety Lead

  • Location

    Paris, Île-de-France

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    competitive benefits and incentives

  • Contact:

    Vladyslav Babych

  • Contact email:

    Vlad.Babych@volt.eu.com

  • Job ref:

    76966-PHARM-VLB_1596727959

  • Published:

    about 1 month ago

  • Expiry date:

    2020-09-05

  • Startdate:

    Q 4 2020 (or immediate start)

Detailed responsibilities:
Prepare the pharmacovigilance part of Marketing Authorization and regulatory dossiers (IND, NDA, Scientific Advice, ...)
Lead the preparation of the Investigator Brochure, IDSURs, PSURs, PDERs, local synthesis and pharmacovigilance reports
Assess the risk / benefit of the products in all indications
Implement and monitor the set-up of pharmacovigilance procedures
Ensure that the pharmacovigilance system can meet international regulatory requirements
Inform and advise health professionals on product safety
Conduct a national and international regulatory and scientific monitoring
Save the reported cases and all pharmacovigilance information in the database
Analyze the reported cases with the investigator if necessary
Manage the Pharmacovigilance team


Experience and Qualification requirements:

PharmaD or Medical Doctor qualification.

Significant and successful experience in pharmacovigilance, with a minimum of 5 years in a global position

Writing experience regarding product safety for study documents and regulatory dossiers

Expertise of the French and international regulatory environment regarding pharmacovigilance

Strong personal leadership and communication skills and the ability to lead a multifunctional team.

Strong scientific and analytic skills with an ability to provide interpretation and an assessment of
complex data.

Good knowledge of relevant regulations and proven evidence of effective delivery of high quality documents as well as relevant concepts in data management and systems, epidemiology and statistics.

Fluent in English