
Safety Professional
1 day ago
Our team is seeking a skilled Pharmacovigilance Manager to lead our pharmacovigilance efforts and ensure the highest level of safety for patients.
The ideal candidate will have a strong background in pharmacovigilance, regulatory affairs, and clinical research. They will be responsible for organizing and maintaining a compliant pharmacovigilance system, ensuring adherence to established processes and guidelines, and leading internal and external audits and inspections.
The Pharmacovigilance Manager will also be responsible for monitoring PV system performance, maintaining expertise in country and worldwide regulations, and promoting awareness of the legislative and regulatory environment. Additionally, they will be accountable for all strategic PV activities and contribute to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile.
Required Skills and Qualifications- Strong knowledge of national/regional regulatory legislation and guidelines.
- Knowledge of the pharmacovigilance regulations of all countries.
- Demonstrated ability to provide quality work using strong organizational, facilitation, and interpersonal skills in a cross-functional team locally, within PV, and externally.
- Skilled at people management, including overseeing and controlling outsourced vendor activities in a compliance/regulated field.
- Capable of troubleshooting and managing multiple projects simultaneously.
- 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.
- Excellent organizational skills and capable of working efficiently.
- Possess excellent interpersonal, verbal, and written communication skills.
This role offers the opportunity to work in a dynamic and fast-paced environment, with a competitive salary and benefits package. The successful candidate will also have the opportunity to develop their skills and knowledge in pharmacovigilance and regulatory affairs.
OthersWe are an equal opportunities employer and welcome applications from all qualified candidates. If you are a motivated and experienced professional looking for a new challenge, please submit your application.
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