Takeda Pharmaceuticals Associate Medical Director, Pharmacovigilance in Cambridge, Massachusetts
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 an Associate Medical Director, Pharmacovigilance in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Medical Director, Pharmacovigilance working on the Medical Safety team, you will be empowered to execute business and Safety related activities for our robust portfolio of global/regional product(s). A typical day will include:
Supporting Global Safety Lead for designated products or, as appropriate, undertaking a GSI role
Responsible for oversight of signal detection and risk management activities for designated global products together with usual safety mandated remit
Flexibility outside of primary therapeutic area as directed by business and departmental need.
Supporting GSL role for compound(s) both in development and marketed in close association with the TAL
As appropriate, being the compound(s) GSL
Intimate awareness of safety for his/her compound responsibilities, including any emerging safety concerns and risk/benefit profile
As appropriate, mentoring/involvement 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
Maintain professional knowledge and accreditation by active participation in continuing medical education activities.
*EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS: *
Minimum of 2-3 years experience in pharmacovigilance, clinical research or clinical development
1 year clinical experience with patients following post-graduate training with significant knowledge of general medicine.
Medical Degree required or internationally recognized equivalent.
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
US – Active license preferred
EU - registered to practice in the EU.
- Some travel to global Takeda sites may be required.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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 attakedajobs.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, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.
Job: *Research and Development
Title: Associate Medical Director, Pharmacovigilance
Requisition ID: 1800592