Medical Director - Pharmacovigilance (PV), Global Medical Safety (remote)

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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), in our Global Medical Safety Team. Position is based virtually (remote)

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
• 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.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws.

For more information, Visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

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Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time