Head Medical Safety Operations

-Designs & develops safety surveillance strategy for products and approval. Responsible for the company s drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products life cycle. Provides safety support to the clinical development teams.

• Manages and coaches a team of Medical Safety Experts/Specialist/Associates.
• Manages the strategic planning of the activities delivered by the Medical Safety Experts/Specialist/Associates.
• Provides strategic leadership within the Medical Safety Operations to ensure compliance in Medical Safety activities and drive compliance and quality to consistently high standards.
• Liaises with the Biosimilars/Generics Medical Safety Heads to get feedback on the performance of the Medical Safety Experts and ensures adequate trainings are put in place
• Supports Biopharma/Generics Medical Safety Heads for overall training of Medical Safety staff.
• Develops effective relationships with internal to PS and external stakeholders to ensure successful execution of the Medical Safety expertise.
• Accountable for enhancement of operational process (e.g. Signal Management, Periodic reporting, Risk Management Plan) to increase productivity, efficiency and quality in order to achieve Medical Safety Excellence.
• Advises and influences the Medical Safety organization on HA regulations and industry practices through close collaboration with Patient Safety and other line functions as well as external forums where Sandoz representation is required
• Acts as a subject matter expert during audits and inspections and leads RCA and CAPA actions.
• Collaborates with External Service Providers to identify and work collaboratively towards addressing evolving needs and ensures effective vendor utilization.
• Maintain oversight on the Safety elements of the Integrated Product List and its impact on Patient Safety processes and deliverables
• Owns and maintains medical safety processes and ensures that they are up to date and in line with the HA regulations.
• Provides guidance on processes to the Countries and regions Patient safety organization as well as other functions outside Medical Safety.
• Responsible for oversight of metrics in scope of Medical Safety Operations

• 6 years in drug development in a major pharmaceutical company (of which 5 are in a global position in safety/clinical/medical affairs or other relevant line function at an operational or medical position)
• Excellent knowledge of HA regulations and PV processes
• Demonstrated people management experience (direct/matrix)
• Strong leadership and people management skills, with ability to successfully lead, engage and develop a highly effective team
• Demonstrated track record of successful work and management of outsourced activities and proven record of excellent communication skills with vendors
• Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal) and presentation skills
• Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure
• Quality oriented
• Good planning, organizational and computer skills

Clinical Research, Clinical Trials, Functional Teams, Leadership, Medical Strategy, Process Safety Management, Regulatory Compliance, Risk Management, Safety Science