Medical Safety Team Lead

What you ll bring to the role :

• Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required. Specialty Board certification desirable.
• Useful additional degrees : Post graduate degree in Pharmacology, Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent).
• 3 years clinical experience postdoctoral
• At least 8 years in Global Safety in a major pharmaceutical company of which at least 2 years were in drug development safety Expertise in preparing or contributing to preparation of clinical safety assessments and regulatory reports / submissions involving safety information
• Strong experience in leading multicultural teams
• Strong experience with (safety or others) issue management
• Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications.
• Strong experience in regulatory requirements, post approval PV methodolgies and product quality assessments
• Strong leadership skills including coaching, motivating, and directing, and fostering teamwork
• Ability to develop and maintain effective working relationships with subordinates, superiors and peers
• Strong negotiation and conflict management skills
• Excellent written and verbal communication skills
• Strong experience with medical writing and delivering high quality documents such as RMPs, PSURs
• Proven administrative skills including the ability to set and achieve goals, and contribute to the development of departmental strategies
• Good project management and time management skills
• Strong knowledge of global regulatory requirements for safety reporting and labeling
• Previous people management experience for at least 3 years
• Fluent in spoken and written English. Understanding in another major language (e.g. French, German, Spanish) desirable

Skills Required

Team Management, Medical Writing, Regulatory Compliance, drug development