Sr. Medical Director, Drug Safety & Pharmacovigilance

The Sr. Medical Director, Drug Safety & Pharmacovigilance is a key position within the company and safety department, with significant impact on the development and life cycle of drug development projects. Responsible for providing safety strategy, expertise, and guidance, pre- and post-approval for assigned products, the Sr. Medical Director will drive the proactive implementation of risk management initiatives in accordance with global regulatory requirements. Core responsibilities will encompass continuous and efficient evaluation of safety data, perform signal detection, evaluation and assessment and management of the safety profile of the compound. In addition, the position will work closely with cross functional teams and Departments for achieving project goals, within timelines & with high quality.

Position Responsibilities:

• Lead and support development of pharmacovigilance strategies for products within Therapeutic area, to ensure compliance with corporate clinical development and commercial goals.
• Oversight and conducting of signal detection activities include monitoring, evaluation, interpretation, management and communication of safety information.
• Responsible for oversight and conduct of Product Safety Committee (PSC) meeting(s) to evaluate risk-benefit for the compounds with support from cross-functional teams. Escalate and present safety issues to the Executive Safety Committee.
• Medical safety review including causality assessment of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing and literature) throughout the development process for assigned compounds/projects.
• Provides medical expert safety review input into all critical documents for products in clinical development (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinical research reports (CSR))
• Oversight of aggregate reports and signal evaluation reports for assigned projects.
• Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Safety topics.
• Provide leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery of services. Ensures vendor oversight of outsourced Medical activities, as applicable.
• Oversee and collaborate with internal safety scientists within TA
• Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws.
• Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., DMCs, Vendor oversight meetings, etc.)
• Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Ability to be flexible and adapt quickly to the changing needs of the organization.
• Support process improvement and functional training at departmental & company level
• Ensure that the highest quality, ethical & professional values are demonstrated in all aspects of work.
• Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulations

Candidate Requirements:

• MD or MBBS or MD-PhD or equivalent medical degree
• 5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance.
• Strong understanding of pharmacovigilance regulations in the US and EU.
• Experience in supporting drug safety activities in registrational clinical studies
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals
• Demonstrated skills in scientific analysis and reasoning.
• Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance.
• Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable
• Strong track record of delivering results through effective team and peer leadership in matrix
• Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies.