Head Medical Safety Assessment and External Engagement

Job Description Summary

The Head of Medical Safety Assessment and External Engagement within Medical Safety Operations, is responsible overseeing the quality of medical review of safety cases in the Novartis Safety system including External Service Providers (ESP). Organize and plan the deliverables of the Medical Safety Experts as per preplanned schedule and ad hoc requests from the Therapeutic Areas, in compliance with Patient Safety business rules. Ensure that the preparation and training of the Medical Safety Experts is provided to a high standard, to deliver activities to the Therapeutic Areas to a high level of quality, timeliness and in a compliant manner. Keeps an oversight of all global vendors/ESPs providing the Medical Safety function with outsourced services across Novartis portfolio.

Job Description

Key Responsibilities

• •Manage the strategic planning of the activities delivered by the Medical Safety Experts within Medical Safety Operations.
• •Lead and contribute to Medical Safety initiatives as well as cross-functional projects (PS&PV) to optimize medical review processes, oversight and quality.
• •Responsible for Medical Safety outsourcing decisions and assessments.
• •Responsible for managing audit/inspection request pertaining to Medical Review of individual cases.
• •Build a high performing team and recruit, retain and develop the best talent; access resource needs on a regular basis to achieve operational efficiency, to provide SME support towards process excellence and to create/maintain a sustainable compliance culture.
• •Liaise with Head Patient Safety of all Development Units to get feedback on the performance and support of the Medical Safety Experts and ensure adequate training is put in place accordingly.

Essential Requirements:

• •Medical Degree or equivalent (preferred), PhD, PharmD
• •Ideally 10 or more years’ experience in drug development including Safety/Pharmacovigilance. At least 3 years of experience in managing medical teams and managing matrix.
• •Excellent negotiation and influencing skills.
• •Ability to mentor, coach associates, and to co-ordinate interactions with internal and external partners.

Desirable Requirements:

• •Proven Leadership in creating and developing global safety/ pharmacovigilance teams and lead strategic growth.
• •Ability to work independently, under pressure, meeting tight deadlines, demonstrating high level of initiative and flexibility. Demonstration effective & innovative leadership.
• •Excellent organizational, planning, resource and global project management skills
• •Superior people management skills with demonstrated positive leadership, innovative, and collaborative behaviors.

Skills Desired

Clinical Research, Clinical Trials, Cross-Functional Teamwork, Leadership, Process Safety Management, Regulatory Compliance, Risk Management, Safety Science, Strategy Development