Medical Director - Pharmacovigilance (PV), Global Medical Safety

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Medical Director - Pharmacovigilance (PV) for our Global Medical Safety team in our Cambridge, Massachusetts office.

OBJECTIVE: 

• Support marketed products: Responsible for the oversight of signal detection and risk management activities for designated global/regional product(s)
• Support Therapeutic Lead: Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs

ACCOUNTABILITIES: 

• Expectation of GSL role for marketed compound(s) in close association with the TAL
• Company-wide safety expert for his/her compound responsibilities
• Intimate knowledge of safety, including any emerging safety concerns and risk/benefit profile for ‘own’ compounds with input for other compounds as needed
• Serving in a leadership capacity for complex and strategically important  programs
• Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities,             expertise in preparing regulatory responses to Pharmacovigilance Risk Assessment Committee (PRAC) and other health authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs, etc.
• Training and mentoring of Pharmacovigilance Physicians and Specialists
• Perform activities required to serve as Global PV physician:
• Review and oversight of safety data, both non-clinical and clinical
• Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities
• Interactions with external experts and regulatory agencies and partner/co-development companies
• Authorship and sign off of Safety Monitoring Plan/Risk Management Plan
• Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
• Direct the set-up of safety procedures and development of safety exchange agreements for co-development projects
• Maintain professional knowledge and accreditation by active participation in continuing medical education activities

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

• Qualified physician (License, e.g. GMC registered, preferred)
• Minimum of 8 years of experience in pharmacovigilance, clinical research or clinical development
• 2-3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine
• Knowledge of principles of epidemiology and statistics.
• Critical thinking and analytical skills and ability to make high level decisions
• Excellent oral and written communication skills including ability to present to large internal/external groups
• Good level of computer literacy with Microsoft applications

WHAT TAKEDA CAN OFFER YOU:

• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement
• Company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time