Senior Medical Director, Pharmacovigilance - Takeda Pharmaceuticals North America

Location: Deerfield, IL
Categories: Director
Website: http://www.tpna.com/positions.asp#top

Position Description

Takeda Pharmaceuticals North America has built a solid foundation on successful products, principles, people, and research. We currently have the following position available in Deerfield, IL:
Senior Medical Director, Pharmacovigilance

RESPONSIBILITIES:
•To oversee the work of all the Pharmacovigilance physicians (EU and US) within TGRD including supervision and support in their GDT, RDT and GSL roles.

•To direct and develop a new global sub-function within Pharmacovigilance. Strategize and implement an approach for proactive safety surveillance, aggregate data analysis and risk management for all TGRD developmental compounds and marketed products for both internal and external global audiences

•To liaise with other TGRD departments (Clinical Research, Regulatory, Pharmaco-epidemiology) to ensure comprehensive product stewardship for both developmental and marketed products.

•Liaise with Head of 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 both marketed and developmental compounds

•Develop and manage pharmacopidemiologic approaches to solving safety issues; including direct utilization of data-mining tools, as necessary, to elucidate and analyze safety issues. 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 and marketed 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.

•Direct safety component of due diligence activities

•Liaise with Associate Director or Director of Pharmacovigilance Systems to contribute to activities to ensure consistency in collection and evaluation of safety data, development of global SOPs and policies to ensure compliance with regional regulatory requirements and to drive improvements

•Contribute to preparations
for external inspections and internal audits

•Understanding Takeda business needs with global business perspective and professional attitude.

•Ensure budget oversight of group including resource assessment for staffing, travel, etc.

•Ensure department goals align with goals of the entire organization

•Maintain professional knowledge and accreditation by active participation in continuing medical education activities.

QUALIFICATIONS:
•
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.

•Knowledge and demonstrated use of epidemiological principles and data mining methodologies.

•Experience in people management and well-developed skills in teambuilding, motivating and developing people.

•Demonstrated skills in negotiation and consensus decision making

•Excellent organization skills and ability to prioritize individual and departmental workloads.

•Multi-tasking with the ability to successfully manage multiple critical issues simultaneously

•Critical thinking and analytical skills and ability to make high level decisions in cross-functional and global environments

•Excellent written and oral communication skills including ability to present to large internal/external groups and strong internal and external networking skills.

•Understanding of and contribution to Takeda business needs and global strategy

•Good level of computer literacy with Microsoft applications

How to Apply

To learn more about this position and to apply online, please visit tpna.com/positions.asp#top and reference job number: 0800425. TPNA is an Equal Opportunity Employer.

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