Director, PV & Medical Safety
Proclinical is currently recruiting for a Director of Medical Safety for a biotechnology company located in Cambridge, MA. Successful candidate 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 including Signal Management, Risk Management, to effectively develop pipeline products and to establish the risk-benefit profile for marketed products.
- Global signal detection and signal management, monitoring, evaluation, interpretation and supports appropriate management.
- Driving the strategy for, provides medical input and risk-benefit assessment to periodic reports.
- Assuring 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. Including: risk management, signal management, throughout the product lifecycle.
- Create and update 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, provide appropriate safety actions and risk mitigation plans.
- Response to inquiries from regulatory authorities on safety issues.
- Integrate safety input into all regulatory documents, where required.
- Represent Medical Safety in PV leadership team.
- Ensure communication of all Global PV and safety issues to Senior PV Management.
- Develop and maintain applicable Standard Operating Procedures.
- Maintain inspection continuous readiness.
Skills and Requirements:
- Medical degree (MD or equivalent) required.
- 10+ years' safety/Pharmacovigilance experience within pharmaceuticals or biotechnology.
- 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.
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) 646-741-8433 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.
Proclinical Staffing is an equal opportunity employer.