PURPOSE OF THE FUNCTION
The purpose of the function is to provide strategic direction and leadership to the Medical and Safety team in order to assure the continuous quality of safety and to ensure timely deliverance of safety services within clinical projects, project teams and business development proposals.
RESPONSIBILITIES
On Departmental level;
* Provides strategic direction on all safety aspects of clinical project set-up and management
* Ensures a high level of medical and safety assessment is maintained within the team
* Ensures adherence to company’s Policies, SOPs, WIs and all applicable regulations and guidelines
* Participates in (project) team meetings in order to provide and support the project team and Medical and Safety team with regard to safety information
* Provides input into proposals and bid defences on safety activities in collaboration with the team
* Manages scientific and medical activities with regard to safety specific issues in order to ensure implementation and proper conduct of protocols
– If applicable, performs Safety Physician responsibilities as indicated in Job Description Safety Physician
* Acts as line manager for the Medical and Safety team, including goal-setting for the team, coaching and encouragement of development of the team members
* Stays abreast of latest developments in safety management, project management and drug development, and contributes to advances in the field
JOB REQUIREMENTS
* Medical Doctor
* Extensive knowledge of safety legislation and regulations and ICH GCP E6
* Good knowledge of the pharmaceutical industry/market
* A minimum of 10 years’ experience, preferably including a minimum of 5 years’ safety experience, in either a pharmaceutical or CRO environment
* 5 years of experience in line management
* Detailed knowledge of the concepts of clinical research and drug development
* Excellent communication skills in both English and Dutch
