Pharmacovigilance Manager

As the global process and business owner for Signal Management, you are responsible for:

• Support the integration of local signal detection and management requirements into the global process
• Lead and manage a team of external service providers who are accountable for detecting and analyzing technical signals from post-marketing surveillance in the signal management tool
• Oversee and ensure maintenance of all Sandoz MedDRA Queries which are used by Patient Safety
• Provide strategic leadership and oversight for all signal detection and management activities conducted by the ESP, leveraging internal and external databases.
• Ensure that all new relevant medical safety signals originating from signal review or analyses from external Health Authority databases are adequately communicated to the respective Safety Lead for further escalation to the SMT.
• Lead audits and inspections as a SME for Safety Signal Management

Experience and Skills:

• Bachelor of Science in Pharmacy /Bachelor of Science in Nursing /PharmD/PhD in relevant field or Medical Degree (MBBS or MD) required.
• Languages: Fluency in English. Knowledge of other languages desirable.
• At least 6 years’ experience in pharmacovigilance operations, including some hands-on experience in performing signal detection and management. Additional hands-on experience in the preparation of aggregate reports, case processing, and risk management plans is a plus.
• Excellent understanding ICH GCP, GVP guidelines, local pharmacovigilance regulations and medical terminology
• Experience with PV audits and inspections and writing and implementation of CAPA