Head of Medical Safety Surveillance
For one of our clients, a leading biopharmaceutical company, we are currently looking for a Head of Medical Safety Surveillance.
- Lead the Medical Safety Surveillance team activities to ensure full compliance with Global Safety regulations, as well as set up of direct reports goals and objectives.
- A key member of the company Drug Safety Committee (DSC) evaluating the safety profile of all Investigational Medicinal Products (IMPs) to ensure that all safety signals are identified early, properly evaluated and managed.
- Active member and provide safety expertise to various internal committees: Protocol Review Committee (PRC), Document Review Committee (DRC) and Quality Assurance (QA) Committee.
- Supervise all activities of drug safety physicians and medical safety writers.
- Provide medical, strategic and pharmacovigilance guidance to all project related activities.
- Analyze and manage complex medical issues, provide effective solution strategies/recommendations and contribute to risk management strategies.
- Develop and implement proper signal detection activities, methodologies and strategies.
- Provide leadership in cross functional submission teams and crisis management team.
- Interface with internal stakeholders including Clinical Development functions, Global Quality Management as well as business partners and regulatory agencies.
- As required, identify and develop contacts with external consultants and opinion leaders to facilitate scientific discussions and develop management strategies for safety issues.
- Act as the lead Drug Safety Physicians for assigned Therapeutic Area Investigational Medicinal products (IMPs).
- Acts as deputy to the Head Global Drug Safety as required.
Qualifications and Experience:
- Doctor of Medicine degree with at least 10-year experience in clinical and post-marketing safety and/or clinical development in the pharmaceutical or biotechnology industry.
- Broad scientific background and excellent clinical development knowledge, experience and ability to interpret clinical study safety information.
- Possessing extensive medicinal product and disease knowledge based on didactic and clinical experience, with considerable additional expertise in safety surveillance and pharmacovigilance.
- Proven record of Health Authority interactions
- Full understanding of the Clinical trials and post-marketing adverse experience reporting systems, experience in product safety monitoring and preparation of investigational and post-marketing regulatory safety reports/documents.
- Extensive knowledge of regulatory principles relative to safety surveillance.
- Knowledge of global safety regulations, Good Clinical Practice (GCP) and Pharmacovigilance compliance requirements
- Excellent medical writing skills are required.
- Previous experience with regulatory filing and contribution to key safety documents such as Integrated Summary Safety document, DSURs. PBRERs, Risk Management Plan, Company Core Data Sheet etc.
- Good experience and knowledge with safety signal identification methodology and risk minimization measures.
- Leadership experience and ability to manage and mentor direct reports are an advantage
- Excellent interpersonal and communication skills.
- Good organizational and planning capabilities
- Fluent in English (oral/written).
- Relevant working/residency permit or Swiss/EU-Citizenship required