Senior Medical Director, Pharmacovigilance and Safety
Abata TherapeuticsFull Time
Senior (5 to 8 years)
Candidates should have advanced leadership experience within a Pharmacovigilance (PV) physician team, potentially including direct line management. Expertise in a specific therapeutic area and indication-specific knowledge is required to provide medical consultation and strategic direction. Experience in managing, mentoring, and overseeing PV physicians globally is necessary. The role requires the ability to interpret safety and efficacy data, conduct risk/benefit evaluations, and perform risk assessments. A strong understanding of quality and reporting compliance for safety reports is essential, along with experience serving as a subject matter expert during audits and inspections. The position requires a minimum of 10-20% travel, potentially including international travel.
The Senior Medical Director will provide global and regional medical leadership and mentoring to PV physicians, serving as a primary point of contact between the PV physician team and other PV leaders. They will offer leadership and strategy to multidisciplinary teams within PV and across the company, focusing on areas such as PV operations, training development, business objectives, quality management, process improvement, compliance, and innovation. Responsibilities include applying therapeutic area expertise to provide medical consultation, strategic direction, and risk mitigation strategies to internal teams and clients, as well as supporting business development activities. The role involves managing resource allocation plans and budgets, serving as the PV physician team liaison with other departments and clients, and potentially overseeing the medical review and analysis of data for clinical trials, aggregate reviews, marketed products, and periodic safety reports. Additionally, the Senior Medical Director will act as a consultant and spokesperson for significant matters concerning the PV organization and collaborate with cross-functional group leaders on strategic process improvement initiatives and training programs.
Provides life sciences products and services
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.