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.
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.
EDUCATION, EXPERIENCE AND SKILLS:
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.
Willingness to travel to various meetings or client sites, including overnight trips. International travel will be required.
We are driven to improve people's lives.
We are an equal opportunity employer.
No Phone Calls or Recruiters Please.