For one of our clients located in the Walloon Brabant (Belgium), we are looking for a Clinical Safety Physician to come on board and join their team.
Job Description
As Clinical Safety Physician, you will coordinate and perform the medical analysis of adverse event reports and/or signal detection activities for assigned projects in clinical development and post-licensure.
You will be the safety contact person for Clinical, Regulatory Affairs, regional and LOC safety managers, manufacturing teams for assigned projects. You will provide medical input to Clinical Teams with respect to safety aspects of the design and preparation of protocols, investigators brochures, investigator letters and reports, for the follow-up and processing of clinical study data and lead the safety analyses of the assigned projects.
You will ensure creation, maintenance and implementation of (D)CSI (Development, Core Safety information) for the assigned projects.
You will ensure provision of the Benefit Risk Assessment and risk identification, assessment and mitigation activities for assigned projects.
Responsibilities
- Perform medical review and provide medical advice on safety-related aspects associated with the assigned projects.
- Signal detection and evaluation of safety for assigned projects.
- Manage the evolving safety profile of assigned projects
- Provide appropriate and timely Benefit Risk Assessments for assigned projects
- Design, tracking and follow up of risk management plans for the products assigned and assure their sound implementation.
- Development and revision of assigned central pharmacovigilance processes and related training.
- Answering and follow-up of enquiries from regulatory authorities and other bodies (e.g., Ethics Committees) regarding safety-related aspects.
- Implementation of the applicable regulations for the assigned projects.
- Participate in IDMC meetings or other safety related interactions with outside collaborators of the assigned projects.
- Implementation and follow-up of safety data exchange agreements for products assigned.
Requirements
- Medical Doctor with 2+ years of experience in the Pharmaceutical or Biotech industry working in Clinical Development, Medical Affairs, Pharmacovigilance, Drug Safety or a related field. and minimum 3 years post-registration clinical experience
- 2+ years of experience in the Pharmaceutical or Biotech industry working in Clinical Development, Medical Affairs, Pharmacovigilance, Drug Safety or a related field.
- Knowledge of Pharmacovigilance and signal detection tools, analysis and reporting of medical safety issues, taking into account the worldwide regulatory requirements.
- Knowledge and experience in collection and interpretation of Serious Adverse Events case reports.
- In depth understanding of the regulatory environment (e.g. International, US and European Legislation).
- Excellent knowledge of safety regulations and working methods.
- Ability to manage crisis, monitor safety issues and work under pressure with a customer and solution oriented approach.
- Able to prioritize activities effectively and to meet multiple deadlines successfully with attention to detail, setting high performance standards for quality
- Demonstrate initiative and creativity in performing task and responsibilities. Proactively contributes ideas to improve existing operations
- Excellent mastery of English, written and spoken with strong communication and influencing skills.
- Integrity and strong feeling for ethics.
- Computer literate, familiar with using scientific and clinical databases.
- Good administrative skills, analytical mind.
- Strong leadership and collaborative working skills
- Existing right to work in Europe is required
Contract information
- Full-time role
- Remote position
