- 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, BEHAVIORAL COMPETENCIES AND SKILLS:
- Medical Degree required or internationally recognized equivalent.
- 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.
- 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
- Some travel to global Takeda sites may be required.
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