Job Description

Medical Safety Assessment Physician | Brussels Area

Belgium Pharmaceuticals Employee
Posted by Luc Decat on 05/05/2020

For a for a leading pharmaceutical company, we are looking for a Medical Safety Assessment Manager for the worldwide Patient Safety Department. The function holder will lead all medical safety assessment and related activities for assigned molecules, in clinical research and already commercialized.

This position is based in Brussels and open for payroll and/or freelance because it is a project of one year, which can possibly be prolonged for an indefinite period afterwards.

 

Key Responsibilities and Major Duties:

  • Leads Safety Management Teams (SMT),

§ 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 the company’s products

§ Serve as safety consultant for product development activities

§ Leader or key contributor to safety query responses

§ Medical safety lead for aggregated 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 WWPS and the company’s cross functional improvement initiatives

 

 

Degree/Experience/Competencies:

  • MD or Equivalent

§ Board certification and/or relevant higher medical training are an asset

§ Minimal 3 years previous experience as medical safety assessment physician

§ Clinical knowledge base as demonstrated by clinical practice experience, or comparable activity

§ Excellent knowledge of ENG, written and spoken

§ Strong written and oral scientific communication skills

§ Strong scientific analytical reasoning skills

§ Behavioral 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

§ 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.

 

Similar Vacancies