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Safety Leader
2 weeks ago
The Pharmacovigilance Manager will oversee the organization and management of a highly compliant PV system. This role requires maintaining awareness and adherence to established local and global processes, as well as national and international regulations.
This includes ensuring PV business continuity, after-hours availability, and leading internal and external audits and inspections. The successful candidate will also be responsible for monitoring PV system performance, compliance of partners and distributors, and promoting awareness of regulatory environments.
Maintaining expertise in country and worldwide regulations and guidelines is essential for this role. Strong organizational, facilitation, and interpersonal skills are necessary to manage cross-functional teams locally, within PV, and externally.
This position involves troubleshooting and managing multiple projects simultaneously. A rational approach to issues, problem-solving skills, and decision-making abilities are crucial. Analytical thinking with attention to detail is required, along with excellent organizational skills and communication abilities.
Required Skills and Qualifications- In-depth knowledge of national/regional regulatory legislation and guidelines
- Familiarity with pharmacovigilance regulations across countries
- Demonstrated ability to provide quality work using strong organizational and interpersonal skills
- Experience in people management, including overseeing outsourced vendor activities in a compliance/regulated field
- Capable of troubleshooting and managing multiple projects
- Strong knowledge and understanding of medical terminology and clinical development processes
- Rational approach to issues and their business implications, good problem-solving and decision-making skills
- Highly analytical with the ability to give attention to detail
At least five years of experience in the pharmaceutical industry and at least five years in pharmacovigilance.
Bachelor's or Advanced degree in medicine or life sciences or equivalent experience.
Excellent communication skills, including proficiency in verbal and written English.
Proficiency in Microsoft Word and Excel.
