Director Safety/Pharmacovigilance

Posted on Mar 17, 2019 by AL2S3 LTD

Not Specified Netherlands
Research & Development
15 Mar 2019
Annual Salary
Full-Time
AL Solutions are currently partnering with a NASDAQ listed Biotechnology organisation focusing in Rare Diseases who are looking for a Director of Safety/Pharmacovigilance to join their rapidly expanding team on a permanent full time basis. My client is located in the Netherlands, however they can offer 3 days home based working per week around Europe. As all of their PV activities are currently outsourced, my client is looking for someone who can build an in house team to manage in the future.

Responsibilities include:

Manage all aspects of safety/pharmacovigilance activities including signal detection, risk management plans, periodic reports (DSURs and PSURs), company core safety information, benefit/risk assessments and individual safety reports for all products/trials.
Review of safety related documents
Prepare high quality case narratives, including identifying relevant information from source documents
Compile safety information for aggregate safety reports and other safety related reports
Perform triage for incoming cases, considering assessments of seriousness and causality
Support preparation of Risk Management Plan and post-marketing safety monitoring activities
Assist in the maintenance of company compliance with respect to laws, regulations and guidance associated with the safety of the patients receiving all medicinal products

Required experience:

Extensive experience in the Pharmaceutical/Biotechnology industry
Strong experience in a safety related role
Fluent in English both written and spoken
Clinical/graduate degree or equivalent (e.g. MD, Pharm D, Ph.D., BSN) required
Expert knowledge of the regulations governing pharmacovigilance
Good working knowledge of validated drug safety databases and MedDRA

My client can offer a very competitive salary and benefits package. For more information on this position, please apply.

Jack Kavanagh

AL Solutions

Reference: 672603879

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