Risk Management Director

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For one of our clients we are searching for a Risk Management Director.

Keywords

• PhD/PharmD/MD
• Risk management
• Drug Safety
• Pharmacovigilance

As Risk Management Director, you are responsible for the development of risk management activities and strategic planning and you are a member of the GD Product sub- teams. It is your responsibility to delineate (define, plan) risk management strategies that are aimed at achieving optimum benefit-risk for products throughout the life cycle of the drug.

Responsibilities:
· Lead the development of policy for project/product risk management strategy (D-Risk Management Plan) and internal and regulatory action plans for real and theoretical safety risks in partnership with the project/product team and advise product teams to ensure clear and balanced communication to senior management;
· Advise product teams in a manner to optimise the implementation of risk management strategies for specific risk assessment activities and documents, co-ordinating and/or authoring documents as appropriate, providing project teams/senior management with a comprehensive recommendation on risk management strategy;
· Organise and provide administrative support to the appropriate governance committees by ensuring that routine updates are provided;
· Advise product teams for development of Investigator Brochure activities where appropriate (i.e., “Advice to Investigators” Section);
· Oversee the policy that is developed for teams that will be responsible for authoring, updating, and maintain the Risk Management Plan (RMP, EU-RMP, REMS), ensuring compliance with current local regulatory requirements. You advise teams to ensure that post marketing risk management activities are aligned with the Risk Management Plan.

Profile

The ideal candidate has a PhD/PharmD or MD, with at least 5-10 years of pharmaceutical/health related industry experience in one or more of the following areas: Drug Safety, Epidemiology and/or Clinical Development, with at least 3-4 years of direct experience in risk management (in a global setting preferred). You understand and can develop risk management strategy, both in a clinical development and a post-marketing setting. You have excellent knowledge of ICH, US & EU regulations and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines required). Are you able to effectively lead cross-functional teams with respect to risk management activities and to influence where direct reporting line relationships do not exist? Then we are looking for you!

Benefits

Project for at least 1 year
Remote (within the Netherlands) possible

Company profile

Our client is a multinational pharmaceutical company, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing.