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Senior Pharmacovigilance Leader
3 weeks ago
We are seeking a Senior Pharmacovigilance Leader to provide strategic direction and leadership for signal detection and management activities in India. This role requires an experienced medical professional with extensive knowledge in global safety practices.
Roles & Responsibilities- Strategic Leadership: Provide vision and guidance for all signal detection and management activities, ensuring alignment with global goals.
- Team Management: Lead and manage a team of safety professionals, overseeing staff recruitment, retention, and professional development.
- Pharmacovigilance Expertise: Ensure smooth interactions with all other Safety groups, providing relevant input on technical processes and contributing to continuous improvement initiatives.
- Collaboration & Communication: Establish effective interfaces with partners outside of the department, such as the technology team, to ensure signal management needs are met.
- A medical degree with at least 6 years of experience in global Pharmacovigilance for a biotechnology or pharmaceutical company.
- A minimum of 3 years of functional management experience overseeing PV staff.
- A thorough understanding of the global PV regulatory environment, including EU and US regulations, ICH guidelines, and GCP.
- A working understanding of drug safety databases.
- Strong analytical problem-solving skills and the ability to provide critical insight quickly.
- Leadership: Strong leadership skills and the ability to oversee multiple projects simultaneously.
- Problem-Solving: The ability to provide astute advice quickly in difficult scenarios.
- Communication: Excellent communication skills for regular interactions with global and cross-functional teams.
- Organization: The ability to successfully manage workload to timelines and a familiarity with basic project management tools.