The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
Our client is seeking a Medical Director in Cambridge, MA.
You will manage the oversight of signal detection and risk management activities for designated global/regional product(s), together with global safety lead responsibly. You will also be responsible for line management responsibilities for junior physicians and/or scientists and support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs. As part of the Global Patient Safety and Evaluations team, you will report to Functional Team Lead, Pharmacovigilance -EPIC and work with the global medical safety teams.
Expectation of Global Safety Lead role for compound(s) in post marketed area in close association with the Functional Team Lead.
Companywide safety expert for your compound responsibilities
• Intimate knowledge of safety, including any latest safety concerns and risk/benefit profile for 'own' compounds with input for other compounds.
• Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, authorship of Executive Summaries on special safety topics, etc.
• Mentoring of Pharmacovigilance Scientists and Specialists
Perform activities required to serve as Global PV physician:
• Review and oversight of safety data
• Review and/or approval of Signal evaluation Report, Aggregate reports, RMP, signals, CCDS including label updates, Health Hazard evaluation and other documents for submission to regulatory authorities
• Interactions with external experts and regulatory agencies and partner companies
• Authorship and sign off Safety Monitoring Plan/Risk Management Plan/Aggregate reports
Skills & Requirements
• Minimum of 8 years' experience in pharmacovigilance ( post marketing preferred)
• 2+ years clinical experience with patients following post-graduate training with knowledge of general medicine
• Knowledge of principles of epidemiology and statistics.
• Critical thinking and analytical skills
• Excellent oral and written communication skills including ability to present to large internal/external groups
This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.
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Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.
Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'. We also believe that actions speak louder than words. In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.
In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.
Drug testing may be required; please contact a recruiter for more information. #1150124
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