MUMBAI, IND
5 days ago
General Manager-CDM/PV
**Job Summary** We are seeking a highly skilled General Manager-CDM/PV with 8 to 10 years of experience in Pharma Research & Development. The ideal candidate will have expertise in PV Case Processing Pharmacovigilance and Safety Operations. This hybrid role offers the opportunity to work in a dynamic environment contributing to the safety and efficacy of pharmaceutical products. **Responsibilities** + Lead the pharmacovigilance team to ensure compliance with regulatory requirements and company policies. + Oversee the processing of PV cases ensuring accuracy and timeliness in reporting. + Provide strategic direction for safety operations aligning with organizational goals. + Collaborate with cross-functional teams to enhance pharmacovigilance processes and systems. + Monitor and analyze safety data to identify trends and potential risks. + Develop and implement risk management plans to mitigate identified safety concerns. + Ensure the effective documentation and reporting of adverse events. + Conduct regular audits and inspections to maintain high standards of compliance. + Train and mentor team members on best practices in pharmacovigilance and safety operations. + Coordinate with regulatory authorities to ensure timely submission of safety reports. + Drive continuous improvement initiatives to enhance the efficiency of PV processes. + Manage the budget and resources for the pharmacovigilance department. + Foster a culture of safety and compliance within the organization. **Qualifications** + Possess a strong background in Pharma Research & Development with at least 8 years of experience. + Demonstrate expertise in PV Case Processing and Pharmacovigilance. + Have a solid understanding of safety operations and regulatory requirements. + Exhibit excellent leadership and team management skills. + Show proficiency in data analysis and risk management. + Have experience in conducting audits and ensuring compliance. + Be adept at collaborating with cross-functional teams. + Possess strong communication and training skills. + Demonstrate the ability to drive continuous improvement initiatives. + Be capable of managing budgets and resources effectively. + Show a commitment to fostering a culture of safety and compliance. + Have a proactive approach to identifying and mitigating risks. + Be detail-oriented with strong organizational skills. **Certifications Required** Certified Pharmacovigilance Professional (CPP) or equivalent certification. Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
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