Medical Director, Medical Safety Assessment

Medical Director, Medical Safety Assessment

Clintec International

Brussels, Belgium

We currently have an exciting opportunity for a Medical Director to join the Clintec team in Braine l’Alleud, Belgium. This position is a contract position initially for 1 year, working office based in Braine l’Alleud, Belgium.

THE ROLE:

As a Medical Director yo u will be responsible for leading all medical safety assessments and related activities for assigned molecules . You will co-ordinate activities between internal teams and clients, ensuring overall safety compliance, according to regulations and SOPs.

Responsibilities include (but are not limited to):

  • 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 BMS products in partnership with other BMS 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 WWPS and BMS cross functional improvement initiatives.

ESSENTIAL CRITERIA:

To be considered for the position of Medical Director candidates should have:

  • Masters Degree or Equivalent;
  • Completed a Board certification and/or relevant higher medical training;
  • 3 or more years previous experience as medical safety assessment physician;
  • Clinical knowledge base as demonstrated by clinical practice experience, or comparable activity;
  • 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 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.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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