Senior Safety Specialist

Location
Île-de-France, France, Paris
Salary
£50364 - £58758 per annum
Posted
24 Jul 2019
Closes
23 Aug 2019
Ref
DT16702
Contact
Daniel Thorp
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Responsibilities:

The Senior Safety Specialist reports to the Director of Drug Safety and Pharmacovigilance. His responsibilities include:
* Provides essential support in the preparation of the key safety documents of the Company (Investigator Brochure, safety sections of Clinical Study Reports,…)
* Prepare the pharmacovigilance part of Marketing Authorization and regulatory dossiers (IND, NDA, Scientific Advice, ...)
* Assess the risk / benefit of the Company products in all indications
* Inform and advise health professionals on product safety
* Provides appropriate representation during regulatory inspections, internal audits and partner audits; collaborates cross-functionally as well as internally with the DS&PV team, Regulatory Affairs and Clinical Development staff


Skills and qualification:

* MD - A specialization in oncology and / or autoimmune diseases would be a plus
* Minimum of 4 to 5 years of clinical or Safety related experience
* Significant writing experience regarding product safety for study documents and regulatory dossiers (Investigator Brochure, safety section of Clinical Study Report,…)
* Demonstrates capability to comprehend medical information
* Ability to prioritize tasks in a timely manner
* Fluent in French and English
* Excellent communication skills, both written and verbal

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