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 limited to report writing & medical… Show more • 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 limited to report writing & medical review).• 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.• Provides expert opinion, guidance and advice to various pharmacovigilance projects associated with medical writing.• Literature review for aggregate reports.• Design and deliver training and development activities to build internal skills and capabilities within the service line• Identify any potential project challenges and suggest possible resolution options.• Contribute as subject matter expert during Health Authorities inspections/audits and contribute in development, implementation of appropriate Corrective and Preventative Actions (CAPA)• Lead recruitment activities in line with demand for services. Show less

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 clinical overview (ACO), Periodic Adverse Drug Experience Reports (PADER), Annual Reports and other.• 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 • 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 clinical overview (ACO), Periodic Adverse Drug Experience Reports (PADER), Annual Reports and other.• Ensure document content and style adheres to appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.• 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• Provide marketing, branding and business development strategies, policies and direction Show less

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