This position will oversee the work of the Clinical Safety physicians who support each therapeutic area. This position will liaise with other TGRD departments (Clinical Research, Regulatory, Pharmaco-epidemiology) to ensure comprehensive product stewardship for developmental products.
EDUCATION, EXPERIENCE AND SKILLS:
- Liaise with VP, Pharmacovigilance and other Directors within Pharmacovigilance department to ensure effective functioning of the department including strategic and long-term planning and resource assessments
- Keep leadership (within and outside Pharmacovigilance) abreast of new developments in safety for developmental compounds
- Work closely with colleagues in TPC PV and TGRD Pharmacoepidemiology to ensure that there is global consensus on signal detection tools and activities
- Provide training and mentorship to PV physicians with respect to medical aspects of surveillance and provide risk management training to other audiences (e.g Clinical Sciences, MSA, Legal, Regulatory, as appropriate)
- Anticipate regulatory implications of emerging safety issues and develop strategies for handling/managing such issues
- Oversee risk management plans for developmental compounds
- High Impact Global Decisions: in conjunction with Head of PV, leads and directs interpretation of safety data from internal and external studies and communicates at senior leadership level the impact of the data in terms of "go/no go" decisions or modification of development plan or study design that may have a significant impact on timeline or product labeling.
- Medical degree required or internationally recognized equivalent.
- Minimum of 8 years experience in pharmacovigilance, clinical research or clinical development, including a minimum of 4 years in a global pharmacovigilance organization. Experience in preparing responses to regulatory agencies on safety-related topics and aggregate analysis of safety data is required.
- 1 year clinical experience with patients following post-graduate training with significant knowledge of general medicine.
- Minimum of 5 years experience in people management and well-developed skills in teambuilding, motivating and developing people.
We are driven to improve people's lives.
- Willingness to travel to various meetings or client sites, including overnight trips. International travel will be required.
We are an equal opportunity employer.
No Phone Calls or Recruiters Please.
Takeda Pharmaceuticals - 18 months ago