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Job Details

Medical Director, Risk Management

Company: only medics recruitment ltd
Location: Boston
Reference: J31332
Closing Date: 20 Dec 17
Type: Full Time
Salary (£): Negotiable
Benefits: Competitive + Benefits

Job Summary:

The successful candidate will lead a team of country level risk management associates to develop and communicate local risk management activities as derived from the company core risk management strategy and plan which applies to all products in the US.

Requirements:

Medical Director, Risk Management required by a world leading pharmaceutical business based in the Boston area.
The successful candidate will lead a team of country level risk management associates to develop and communicate local risk management activities as derived from the company core risk management strategy and plan which applies to all products in the US. Direct cross functional teams providing collaboration and support for risk management initiatives and development of risk communication approaches and plans, leveraging informational and educational needs of customers into evidence based programs.

Responsibilities
* Serve as the departmental lead for the development and oversight of corporate development project teams at the time when US risk management adaptations of the company core risk management strategies are being initiated.
* Direct cross functional teams providing collaboration and support for Risk Management activities whether part of the local risk management plan or REMS, leveraging informational and educational needs of customers into evidence based strategies and programs.
* Acquire full knowledge of the safety specifications and context motivating the company core RMP and REMS; consult appropriate experts and functions to propose local adaptations to a global Pharmacovigilance plan.
* Surveillance of new or changing risk management communications, regulations and guidance from US FDA; communication of these relevant notifications to the GPE Stakeholders: Country Safety Lead/Regional Safety Lead and to GBU PV Groups, Risk Management Center of Excellence, Safety Regulatory Intelligence in Global PV Policy, Global Safety Sciences; oversee implementation of necessary changes in US risk management activities as warranted based upon this FDA Intelligence surveillance
* Development and maintenance of Standard Operating Procedures (SOPs) around risk management
* Ensure adequate training of US Pharmacovigilance personnel in US risk management
* Ensure compliance with safety-related post-marketing commitments to FDA, in collaboration with Quality Standards and Training team.

Requirements
* Doctorate degree from an accredited college or university (e.g., M.D., J.D.,PhD, PharmD, or equivalent)
* MD (Board certification or eligibility) preferred; PhD or PharmD with risk management experience.
* Progressive experience in the Pharmaceutical or Biotech Industry working in in multiple areas including pre-clinical or clinical drug development, Pharmacovigilance, regulatory affairs, medical affairs, pharmaco-epidemiology, market research, health outcome research, within the pharmaceutical/medical device industry or a public health institution, totaling seven to ten years.

Apply for this job: Medical Director, Risk Management

Contact Information:

Address:  Head Office
3rd Floor
33 Station Road
Reading
Berkshire
RG1 1PW
England
Tel:  +44 (0)1189 522 799
Fax:  +44 (0)1189 560 607
Website:  Visit Our Web Site

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