Medical Safety Director

Key Responsibilities and Major Duties:

Leads Medical Surveillance Teams in the area of Signal Detection/Safety surveillance, evaluate and integrate data from multiple sources, including clinical, non-clinical and real-world, to understand and manage safety signals.

Accountable for risk strategy, risk assessment and risk minimization for company products in partnership with other company functions.

Serve as safety consultant for product development activities.

Leader or key contributor to safety query responses.

Medical safety lead for aggregate safety reports and strategic documents.

Serve as a trusted partner to other R&D functions in representing the view on product safety, and lead in a matrix environment through scientific competency and organizational influence and impact.

Contributes to GPVE and cross functional improvement initiatives.

Degree/Certification/LicensureMD or Equivalent: Has completed a Board certification and/or relevant higher medical training.

Competencies/ knowledge, skills, abilities:

Clinical knowledge base as demonstrated by clinical practice experience, or comparable activity Strong written and oral scientific communication skills

Strong scientific analytical reasoning skills

Behavioural competencies necessary to work and lead within a complex matrix environment Understanding of drug development process, with knowledge of design and execution of randomized clinical trials

Knowledge of pharmacovigilance and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product

Understanding of regulatory requirements for safety assessment and action through the life cycle of a drug product.

Ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.