Join Takeda as a Medical Director, PV, GI where you will support developmental programs, including both early and late-stage development. You will also manage the oversight of signal detection and risk management activities for designated global/regional product(s), together with the 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 the 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 Executive Medical Director, Pharmacovigilance - GI, and work with the global medical safety teams
Roles and Responsibilities
- The expectation of the Global Safety Lead role for compound(s) both in development and marketing in close association with the Therapeutic Area Lead.
- Company-wide 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.
- Serve in a leadership capacity for complex and important programs.
- Responsible for the 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, contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs, etc.
- Mentoring of Pharmacovigilance Physicians and Specialists.
- Perform activities required to serve as a Global PV physician:
- Review and oversight of safety data, both non-clinical and clinical.
- Review and/or approval 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 companies.
- Review safety data and participate in dose escalation decisions.
- Authorship and sign-off of the Safety Monitoring Plan/Risk Management Plan.
- Qualified physician (Licence, e.g. GMC registered, preferred).
- Minimum of 8 years experience in pharmacovigilance, clinical research, or clinical development.
- 2+ years of 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 the ability to present to large internal/external groups.