Job Description
The consultant will actively manage and evaluate risks associated with assigned vaccine projects, and make recommendations for the management and communication of risks in accordance with global legal
and regulatory frameworks. This will involve working in partnership with the Vaccine Clinical Safety and Pharmacovigilance Scientist.
Responsibilities
- You coordinate and perform the medical analysis of adverse event reports and/or signal detection activities for assigned vaccine projects in clinical development and post-licensure
- You are the safety contact person for Clinical, Regulatory Affairs, regional and LOC (local operating company) safety managers, manufacturing teams for assigned vaccine projects
- You 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 ensure creation, maintenance and implementation of (D)CSI (Development, Core Safety Information) for the assigned projects.
- You ensure provision of the Benefit Risk Assessment and risk identification, assessment and mitigation activities for assigned vaccine projects
- You perform medical review and provide medical advice on safety-related aspects associated with the assigned vaccines.
- You signal detection and evaluation of safety for assigned projects.
- You manage the evolving safety profile of assigned vaccine projects
- You provide appropriate and timely Benefit Risk Assessments for assigned vaccine projects
- You design, tracking and follow up of risk management plans for the products assigned and assure their sound implementation.
- You lead the Safety Review Team and be VLT (Vaccine Leadership Team) member for assigned vaccine projects
- You develop and review assigned central pharmacovigilance processes and related training.
- You answer and follow-up of enquiries from regulatory authorities and other bodies (e.g., Ethics Committees) regarding safety-related aspects.
- You implement the applicable regulations for the assigned vaccines.
- You participate in IDMC meetings or other safety related interactions with outside collaborators of the assigned vaccine projects.
- You implement and follow-up safety data exchange agreements for products assigned.
- You make independent clinical assessments and decisions, based on professional and scientific responsibilities to patients, prescribers, regulators, and providers.
- You generate reliable evaluations and recommendations from safety data from large and multinational study environment (200,000 subjects for the ongoing studies)
- You provide scientifically based safety assessments within complex public environment.
- You lead cross-functional interactions within the company, such as clinical, regulatory affairs, biostatistics, data management, manufacturing and legal.
- You provide external reference for any safety-related request from local authorities and participate in external meetings with regulatory agencies or present.
- You are a Medical Doctor with preferred speciality in Infectious Diseases, Epidemiology or Vaccines
- You have at least 3 years of post-registration clinical experience and 2 years of experience in the Pharmaceutical or Biotech industry working in Clinical Development, Medical Affairs, Pharmacovigilance, Drug Safety or a related field.
- You have knowledge of Pharmacovigilance and signal detection tools, analysis and reporting of medical safety issues for vaccines, taking into account the worldwide regulatory requirements.
- You have knowledge and experience in collection and interpretation of Serious Adverse Events case reports.
- You have an in depth understanding of the regulatory environment (e.g. International, US and European Legislation).
- You have a very good understanding of vaccine development process
- You have an excellent knowledge of safety regulations and working methods.
- You have the ability to manage crisis, monitor safety issues and work under pressure with a customer and solution oriented approach.
- You are able to prioritize activities effectively and to meet multiple deadlines successfully with attention to detail, setting high performance standards for quality
- You demonstrate initiative and creativity in performing task and responsibilities.
- You have an excellent knowledge of English, written and spoken with strong communication and influencing skills.
- You are computer literate, familiar with using scientific and clinical databases.
- You have strong leadership and collaborative working skills