- Coordinate and perform the medical analysis of adverse event reports and/or signal detection activities for assigned projects in clinical development and post-licence activities
- Be the safety contact person for Clinical, Regulatory Affairs, regional and local safety managers, manufacturing teams for assigned projects
- 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 analysis of the assigned projects
- Ensure creation, maintenance and implementation of Development Core Safety Information for the assigned projects
- Ensure provision of the Benefit Risk Assessment and risk identification, assessment and mitigation activities for assigned projects
Role and main tasks:
- Perform medical review and provide medical advice on safety-related aspects associated with the assigned products
- 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
- Lead the Safety Review Team and be team member for assigned projects
- Development and revision of assigned central pharmacovigilance processes and related training
- Answering and follow-up of inquiries from regulatory authorities and other bodies regarding safety-related aspects
- Implementation of the applicable regulations for the assigned products
- Participate in 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
- Medical Doctor with preferred specialism in Infectious Diseases, Epidemiology or Vaccines.
- 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
- English a MUST and French skills are ideal
- Experience in Clinical Studies an asset
- 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 prioritise 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
What we offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our ‘human’ approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
- From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.