
Pharmacovigilance Professional
2 days ago
Our organization requires a professional to oversee the implementation and maintenance of a pharmacovigilance system that ensures compliance with national and international regulations.
This role is responsible for monitoring the performance and compliance of the pharmacovigilance system, as well as maintaining expertise in country and worldwide regulations.
- Organize and manage a compliant pharmacovigilance system
- Maintain awareness and adherence to national and international regulations and guidelines
- Lead internal and external audits and inspections
- Monitor PV system performance and compliance of partners and distributors
- Maintain expertise in country and worldwide regulations
- Accountable for strategic PV activities
- Contribute to monitoring safety profiles
Required Skills and Qualifications:
- In-depth knowledge of national/regional regulatory legislation and guidelines
- Knowledge of pharmacovigilance regulations
- Strong organizational and interpersonal skills
- People management and project management skills
- Medical terminology and clinical development process understanding
Minimum Requirements:
- 5 years of experience within the pharmaceutical industry and 5 years within pharmacovigilance
- Medicine or life sciences degree/advanced degree or equivalent experience
- Excellent communication skills in English
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