
Leading Pharmacovigilance Expert
8 hours ago
We are seeking a highly skilled Pharmacovigilance Manager to oversee the implementation and maintenance of pharmacovigilance systems.
">- Organize, manage and maintain a compliant Pharmacovigilance system.
- Maintain awareness and adherence to established processes, national and international regulations, and guidelines for pharmacovigilance.
- Ensure business continuity and after-hours availability.
- Lead and coordinate internal and external PV audits and inspections.
- Monitor PV system performance and compliance of partners and distributors.
- Maintain expertise in country and worldwide regulations, promoting increased awareness of the legislative environment.
- Accountable for strategic PV activities.
- Contribute to monitoring the safety profile.
- Act as the responsible contact person for safety-related aspects and PV.
- Ensure well-documented regulatory/PV processes support compliant activities.
- Perform other duties as assigned.
- In-depth knowledge of national/regional regulatory legislation.
- Knowledge of pharmacovigilance regulations across countries.
- Strong organizational, facilitation, and interpersonal skills in a cross-functional team.
- Skilled at people management, including overseeing outsourced vendor activities.
- Capable of troubleshooting and managing multiple projects simultaneously.
- Strong medical terminology and clinical development process understanding.
- Rational approach, problem-solving, and decision-making skills.
- Highly analytical with attention to detail.
- Excellent organizational skills and communication abilities.
- Minimum five years of pharmaceutical industry experience and five years in pharmacovigilance.
- Advanced degree in medicine or life sciences or equivalent experience.
- Excellent verbal and written English proficiency.
- Experience in affiliate medical functions or global clinical product development is advantageous.
- Proficiency in Microsoft Word and Excel.
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