Senior Manager, Data Management

4 days ago

India Novaspire Biosciences Full time
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.

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.

• 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.

• Active contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile

• Ensure internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities.

• 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

• 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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