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Global Safety Physician

Job Title: Global Safety Physician
Contract Type: Permanent
Location: Rhône, Rhône-Alpes
Industry:
Salary: £90000 - £105000 per annum + bonus and relocation
Start Date: asap
Reference: 69274-PHARM-VLB_1508522205
Contact Name: Vladyslav Babych
Contact Email: Vladyslav.Babych@volt.eu.com
Job Published: October 20, 2017 18:56

Job Description

This opportunity will suit someone who has a strong background in global safety projects and will allow you to build and grow your team whilst having full support and tools available with international company.
My client has a professional environment which will suit individuals with passion to their role and high ethical values.
The main purpose of the role is:
Adequate medical management of individual case reports (ICSRs)
 Providing Global Medical Safety Expertise for assigned product(s)
 Delivering contribution and advice as global drug safety expert for assigned products to Drug Safety Governance meetings and various other cross-functional team meetings

Main tasks and responsibilities:

* Coordinating the detection of signals;
*Contributing to the review of PV cases and documents related to the products of your portfolio;
*Achieving and coordinating the monthly quality control of the adverse events;
*Coordinating the safety reports writing ;
*Participating actively to the redaction of the risk management plan ;
*Contributing to the training of Pharmacovigilance procedures
*You will represent Global Safety team on interdisciplinary project teams

Minimum experience and qualifications
*Medical Doctor,
*Possess strong knowledge of pharmacovigilance and clinical safety
*Experience in Global Safety setting (min 3 years)
*Ability to write PSUR ( Periodic Safety Update Report) and DSUR ( Development Safety Update Report), RMP (Risk Management Plans), AE/SAE evaluation, writing of narratives, ongoing safety review during study; individual cases reviews and other safety documents
*Oncology products and/or clinical experienced is a plus
*Up-to-date knowledge of European and Global Safety regulations and safety procedures
*Ability to take initiative and lead the team
*Strong analytical skills and attention to details
*Fluent in English, other European language is a plus