
Safety Manager
2 days ago
We are seeking a seasoned professional to oversee the management of our Pharmacovigilance system. The successful candidate will be responsible for ensuring compliance with established processes and guidelines, as well as national and international regulations.
The role involves organizing and maintaining a highly compliant Pharmacovigilance system, monitoring performance and compliance, and leading internal and external audits and inspections. Additionally, the candidate 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.
The ideal candidate will have in-depth knowledge of national/regional regulatory legislation and guidelines, as well as demonstrated ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team.
Required Skills and Qualifications
- In depth knowledge of national/regional regulatory legislation and guidelines
- Knowledge of the pharmacovigilance regulations of all the countries
- Demonstrated ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team locally, within PV and externally
Skills and Abilities
The successful candidate will possess an excellent interpersonal, verbal, and written communication skills. Additionally, they will have 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.
Minimum Requirements
- Minimum five years of working experience within the pharmaceutical industry and minimum five years within pharmacovigilance
- Degree / Advanced degree in medicine or in life sciences or equivalent experience
- Excellent communication skills including proficiency in verbal and written English
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