Ajit Mane

About Ajit Mane

Pharmacovigilance leader with over 16 years of progressive experience in global and local…

Experience

1. Manager Pharmacovigilance and Drug Safety

   Syneos Health

   Mar 2023 — Present · Pune, IN

   Line-managed global safety teams, ensuring GVP, HIPAA, GCP, and local regulatory compliance.• Participates in process development, budget reviews, and project management. Ensures consistency and communication between the Safety team members and management.• Line management responsibilities including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, time sheet approval, and employee counselling. Advises staff on administrative policies and procedures, technical problems, and prioritization.• Assigns project work and reviews workload for all direct reports. Provides oversight and guidance on organizational goals and company objectives. • Monitors quality of work and efficiency of team members with contracted scope of work and Safety Management Plan. Discusses below-target project goals with senior safety management.• Provides sponsors with scheduled project updates and reports.• Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs).• Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety Reporting Plan.• Evaluate and participate in process development and improvement of departmental functions.• Works with Business Development to actively solicit new business, as needed.• Represents Safety and PV team at project team meetings and client meetings.• Participates in bid defense meetings.• Maintains understanding and ensures compliance of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP modules, study plans and the drug development process.• Responsible for the identification, preparation, and delivery of any necessary training to Safety team members and other Syneos Health departments or groups. Mentor Safety team members.• Participates in audits/inspections and ensures inspection readiness.• Participates in quality investigations, RCA & CAPA)

Education

• NVTS COLLEGE OF PHARMACY

  Diploma in Pharmacy

• Shivaji University

  B.pharm, Science

  2006 — 2009

• Dr. D Y Patil Vidyapeeth - Centre for Online Learning

  Master of Business Administration - MBA, Hospital and Health Care Facilities Administration/Management

Skills

• Edc
• Regulatory Affairs
• Pharmacovigilance
• Management
• Clinical Data Management
• Medical Writing
• CRO
• Clinical Trials
• Pharmaceutical Industry
• Sop
• Data Management
• Ich-Gcp
• Gcp
• 21 Cfr Part 11