Medical Safety Team Lead

Job Description

- Recruits and manages a team
- Develops objectives for Medical Safety in collaboration with other Medical Safety Team leads and MSO head in alignment with Patient Safety and Sandoz Goals and Objectives.
- Development and retention of talents. Leads the performance management process for their team
- Leads the day-to-day safety activities of the assigned team as per allocated portfolio. Oversees the assignment of activities within the team and ensures the timely delivery and appropriate quality oversight of Sandoz safety deliverables, including but not limited to Medical Risk Assessments, PSURs and RMPs
- Enhances operational, scientific and clinical experience of Safety Leads/Experts through continuous training and coaching.
- In collaboration with other leaders from Medical Safety (as applicable), is responsible for responses to inquiries from regulatory authorities and internal stakeholders on safety issues. Support in preparation of safety data for health authority review boards (together with the Sandoz clinical and biostatistical functions). Attends Health Authority meetings, as required.
- Ensures safety information is communicated/escalated to HMS/HPS/Sandoz Management and/or EU Qualified Person in a timely fashion.
- May be required to coordinate and presents safety issues to internal Sandoz Boards and other meetings as required. Provides relevant input for SMT and other governance boards as needed
- May be assigned high profile product from the portfolio.
- Initiates and maintains productive cross-functional Medical Safety collaborations with colleagues within other functions within and outside Patient Safety.
- Ensures tasks are performed as per applicable procedures (e.g., GOPs, SOPs, WIs), assigned to the role.
- Keeps working instructions / SOPs / GOPs for the area of responsibility up to date with internal (e.g., QMs) and external (e.g., GVP modules) requirements. Works closely with other functions to ensure requirements for Medical Safety are represented in safety processes and works closely with other team leads across Medical Safety to ensure PV activities are appropriately represented in Sandoz procedural documents. Ensures implementation of such procedural documents in the area of responsibility.
- Actively engages in process and system development to ensure the needs of Medical Safety portfolio is included at the design and implementation phases
- Provides Medical Safety input for licensing activities, internal audits, regulatory authority inspections and for project /product recall activities.
- Deputizes for Head Medical Safety (HMS) and perform delegated tasks as required
- May Chair the Medical Safety Review Board.
- May be required to represent Medical Safety at Senior Sandoz Boards as per assigned portfolio and external forums.
- Co-lead with HMS the continuous Medical Safety learning program.

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

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