Pharmacovigileance Manager job in Paris, France

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Pharmacovigilance

Location: France

This vacancy has now expired. Please see similar roles below...

A vacancy has arisen for a Pharmacovigilance Manager to join a pharmaceutical company in France, in this role you will be expected to oversee all pharmacovigilance activities

Job Requirements

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 standards
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
Analyse the reported cases with the investigator if necessary
Manage the Pharmacovigilance team

Skills and Requirements

PharmaD or MedicalD - A specialization in oncology and / or autoimmune diseases would be a plus
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
Fluent in French and English

To Apply

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

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