Director, Medical Safety job in Boston, Massachusetts

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At Proclinical, we are seeking an experienced safety physician to fill the role of Director of Medical Safety, based in Boston, MA. The successful individual will be responsible for developing a highly strategic and compliant Pharmacovigilance function. The incumbent will be part of the Senior PV Leadership Team, reporting directly to the Vice President and Head of global Pharmacovigilance (PV) with the primary focus of creating the global Medical Safety function.

Responsibilities

Managerial oversight of the Medical Safety function.

Perform global signal detection and signal management, monitoring, evaluation, interpretation and supports appropriate management.
Assure processes are in place and appropriate for decision making around risk-benefit profile, risk minimization, etc.
Supporting mentoring and training on the implementation and execution of safety practices.
Lead the creation and updating of Company Core Safety Information (CCSI), Reference Safety Information (RSI) and safety portions of other labeling.
Provide expert safety input to the clinical development program for assigned projects.
Provide senior PV Leadership with ongoing updates of the changing risk-benefit profile of products in development and marketed products.
Respond to inquiries from regulatory authorities on safety issues.
Communicate all global PV and safety issues to senior PV management.
Develop and maintain applicable Standard Operating Procedures.
Maintaining inspection continuous readiness.

Skills And Qualifications

MD or equivalent and 5-10 years of relevant experience.
Experience in pre-marketing setting, additional experience in post-marketing setting is preferred.
Global experience is preferred.
Thorough understanding of pharmacovigilance regulations and guidelines esp. FDA, EMA, and ICH.
Working knowledge of MedDRA including SMQs.
Occasional travel required.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Yannick Dada at (+1) 6467418433 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

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