Safety and Compliance Specialist
1 day ago
We are seeking an experienced Pharmacovigilance Manager to join our team at Novaspire Biosciences. The ideal candidate will have a strong background in pharmacovigilance and excellent organizational skills.
Main Responsibilities:- Organize, manage, and maintain a highly compliant PV system.
- Maintain awareness and ensure adherence to established and updated local and global processes and guidelines as well as national and international regulations and guidelines for pharmacovigilance.
- Ensure PV 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 as well as worldwide regulations and guidelines and promote increased awareness of the legislative and regulatory environment in the country.
- Accountable for all strategic PV activities.
- Active contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile.
- Act as the responsible contact person in the region, internally and externally, for safety-related aspects and PV.
- Ensure internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities.
- 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.
- Experience in other affiliate medical functions (e.g., Medical Affairs, Clinical Operations, Medical Information) or global clinical product development is considered advantageous.
- Proficiency in Microsoft Word and Excel.
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