Assistant Manager at Syntel Ltd
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Syntel - Pharmacovigilance Expert (8-15 yrs)
Resource should be responsible to provide leadership to multiple Pharmacovigilance offerings including business development activities
Responsibilities:
- Builds effective, high performing PV / Clinical safety Management teams through influence, integration, motivation and optimizing team performance. Embeds the values into the team culture and promotes team spirit.
- Medical review of aggregate reports such us PSURs, PADERs & RMPs
- Performing Signal review as assigned by clients
- Medical review of cases as assigned by clients
- Data migration project management of cases from legacy data base to COTs
- Participate in risk management meetings conducted by client
- Responsible for the timely evaluation of safety signals from various sources including automated tools.
- Ensure compliance and management of safety signals according to the SOPs and Global HA guidelines
- Interaction with Global project teams to ensure evaluation and management of Safety Signals occur with Global compliance.
- Provide inputs to various safety review boards.
- Guide and advice global teams in the process of signal evaluation and management.
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