Pharmacovigilance Manager

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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