Team Manager-Medical Affairs Full-time Job1 week ago - Pharma - Mumbai - 13 views
• Capability to lead and get the assigned projects completed
• Project planning, Budgeting, Effective utilization of Resources
• Good to liaise with other discipline to organize necessary support.
• To execute projects
• Good exposure to Safety guidelines
• To implements cost cutting techniques without compromising quality.
• Should be good in training, communication and team management.
Job Purpose :
To assess, design, develop, deliver and evaluate skill / competency learning and development programs for the Marketing Team and specific assigned projects.
• Processing of serious adverse effects (SAEs) and submission to regulatory agencies for both spontaneous reporting, Post marketing surveillance (PMS) SAE reporting and clinical trial SAE reporting
• Ensuring submission of SAEs to respective Ethics committee (ECs), Head of institution and principle investigator (PI) in case of clinical trial reporting.
• Coordination and correspondence with internal and external stakeholders during the post marketing SAE processing
• Establish and maintain working relationships with partners and customers – Co-ordinate and regularly communicate with internal and external stakeholders (including project teams, Health authority/ journals/ medicals and scientific associates etc.) for pharmacovigilance deliverables
• Prepare and review Medical Monitoring Plan (MMP) or Safety Management Plan (SMP) during clinical trial initiation.
• Prepare and review Periodic Safety Update Report (PSUR), Risk Management Plan (RMP), and Company core data sheet (CCDS) and Company core safety information (CCSI) for all new marketed and exported products.
• Maintain and update the PV trackers, PV binders (per project) for PV related documents.
• Handling of Pharmacovigilance Software and case processing of ICSRs and SAE of Ongoing Clinical Trials and Post Marketed Products
• Maintain and update the PV trackers, PV binders (per project) for PV related documents
• Ensuring the compliance of Clinical Trials and Regulatory requirements of safety information as per timelines
Outcomes and KPIs
• Ensure all assigned projects are delivered as per expectations
• Ensure all the Individual case safety reports ICSRs and Serious adverse reports are submitted to regulatory authorities as per timelines
• Ensure all the deliverables for International P2P partners which includes PSUR and RMP as per timelines
• Ensure all the internal and external stake holders are regularly trained with Good Pharmacovigilance Practices
• Ensure Training for Business Executives and Marketing group Pharmacovigilance Training as per the planned yearly schedule
• Direct learning to handle enhanced job roles.
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