Sanjeev Kumar Email & Phone Number

Hyderabad Area, India

• US PADERs, Annual Safety Reports, EU PBRER and ROW PBRERs Services delivery Management to Global customers
• Single point of contact for signal management and aggregate reports, to ensure smooth functioning of the project.
• PADER/PBRER: - Provides assistance in Periodic Adverse Drug experience Report (PADER) Periodic Safety Update Reports (PSUR) and Addendum to Clinical Overview (ACO), DSUR etc. related activities (including but not.
• PADER/PBRER: - Provides assistance in Periodic Adverse Drug experience Report (PADER) Periodic Safety Update Reports (PSUR) and Addendum to Clinical Overview (ACO), DSUR etc. related activities (including but not.
• Management Plans (RMP) and its related activities within internal timelines.
• Signal Detection: - Preparation and QC of signal detection reports including detection, evaluation, assessment and related activities.

Chandigarh Area, India

• Author various safety reports (or part of such reports) for global regulatory submissions for clients, including Periodic Benefit-Risk Evaluation Report (PBRER), Periodic Safety Update Reports (PSUR), Addendum to the.
• Ensure document content and style adheres to appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
• Work… Show more
• Work with all other onshore and offshore therapeutic area and shared service roles to promote consistent operations, efficient use of resources and sharing knowledge/best practices
• Manuscripts designing and medico marketing.
• Consistent screening of publications and databases for drug safety operations

New Delhi Area, India

Managing Medical Information, Adverse event complaints and Quality complaints.Update with latest scientific product information Liasoning with corporate pharmacovigilance and quality teams for query resolution and closure

New Delhi Area, India

New Delhi Area, India