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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 in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Medical Director working on the Pharmacovigilance team, you will be empowered to Innovate and Strategize. A typical day will include:

POSITION OBJECTIVES:

• Support developmental programs, including both early and late stage development as required.
• Responsible for the oversight of signal detection and risk management activities for designated global/regional product(s), together with global safety lead responsibly as appropriate.
• Supporting Therapeutic Lead
• Line management responsibilities for junior physicians and/or scientists
• Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs

POSITION ACCOUNTABILITIES:

• Expectation of GSL role for compound(s) both in development and marketed 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, 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
  • Review of safety data and participate in dose escalation decisions
  • 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, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Qualified physician (Licence, e.g. GMC registered, preferred)
• 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

• Minimum of 8 years 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

TRAVEL REQUIREMENTS:

• Estimated 5-10 times per year including international travel

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
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time