Job Purpose:
The Manager, PV Operations will manage and supervise project’s PV Operations staff on a day-to-day basis, guiding performance of PV Operations staff in ongoing projects in terms of quality of deliverables, compliance with the timelines and relevant trainings. He/she will also provide process-related expertise for the various project specific activities including but not limited to processing of Individual Case Safety Reports, Signal and risk management, Regulatory operations and Medical writing, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs) and communicate with client for queries/feedback.
Skills:
• Excellent leadership and line management skills
• Excellent knowledge of drug safety and the drug development process
• Excellent knowledge of and ability to interpret and apply global safety regulations
• Experience in data analysis, evaluation of safety data and the preparation of safety reports
• Excellent team / project leadership and delegation skills
• Ability to train and mentor people
• Excellent presentation skills
• Excellent interpersonal skills
• Excellent verbal / written communication skills
• Excellent time management skills
• Client focused approach to work
• Experience with computer applications including database management and Pharmacovigilance related computing systems
Knowledge and Experience:
• Considerable drug safety knowledge and experience
• Minimum 8 Years experience in pharmacovigilance/drug safety or allied fields and people management