Pharmacovigilance Manager
2 weeks ago
Company Description
At Novaspire Biosciences, we pride ourselves on being a trusted partner to the pharmaceutical industry, delivering comprehensive, high-quality clinical research services. We specialize in supporting pharmaceutical, biotechnology, medical device, and nutraceutical companies at every stage of the drug/product development lifecycle, from clinical studies Phase I to post-market surveillance. Our core services include pharmacovigilance, clinical trials, medical writing, bioequivalence study support, GxP consulting services & training, and imaging studies. With over 75 years of combined experience, our team provides solutions and streamlined processes to ensure efficient and effective research outcomes.
Role Description
• Organize, manage and maintain a highly compliant Pharmacovigilance (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.
• Perform other duties as assigned.
Skills Required:
• 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.
• 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 an excellent interpersonal, verbal, and written communication skills.
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
• 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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