- Coordinate and perform the medical analysis of adverse event reports and/or signal detection activities for assigned projects in clinical development and post-licensure
- Be the safety contact person for Clinical, Regulatory Affairs, regional and LOC (local operating company) 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 analyses of the assigned projects.
- Ensure creation, maintenance and implementation of (D)CSI (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
- 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.
- Medical Doctor and a high level of medical competence
- Minimum 2 years of prior experience in the Pharmaceutical 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 for vaccines, 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).
Additional Desirable Skills:
- 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