Ashwin Kumar M Email & Phone Number

Hyderabad, IN

Prepare proposal in alignment with the requirement of customers in RFPs related to Pharmacovigilance, Medical information, Medical Writing, and regulatory Affairs. with technical inputs from operationsPrepare/build on budget from the technical inputs and pricing received from finance team.To work collaboratively with inside sales team and support in.

Support activities during the RFP stage of proposal by working with the implementation / project team, articulating customer requirement, to ensure smooth transition from Sales to Delivery.Build repository of responses to Frequently asked questions (FAQs) within RFPs and RFIs and to improve quality of the content.By interfacing with existing and.

Hyderabad, Telangana, India

Hyderabad, Telangana, India

• Setup of new PV projects, SOP/WI development, KPI management of project and individual members. Skilled in product portfolio management including focal point for single global business units.
• Conduct training on pharmacovigilance for new business or expansion of the existing business. Extensive project setup, team management and resource planning.
• Establishing PV global strategy and leading PV business development activities and initiatives, including:
• Mapping clients requirements and taking initiatives for maximizing client base by maintaining regular contact with key clients.
• Overseeing the development of and life-cycle management of Safety Data Exchange Agreements (SDEAs) and PV Agreements (PVAs).
• Worked cross-functionally to ensure global alignment from key stakeholders by maintaining effective and efficient working relationships with Alliance Partners.

Hyderabad Area, India

• Role as Operations Lead (Pharmacovigilance):
• Take part in the daily management of the PV projects.
• Responsible for successful delivery of service.
• Monitor compliance with regulations, PV agreements and internal SOPs.
• CAPA Late case analysis and TAT analysis.
• Provide pharmacovigilance training to internal staff.

Mysuru, Karnataka, India

• Role-Quality Reviewer:
• Perform QC review of all processed cases by Data entry associates, in terms of accuracy compared to source documents and information, prioritizing QC review of serious cases in safety database.
• Check all fields against source information
• Error/discrepancy correction
• Narrative consistency check in line with source information and structured fields
• Mentor and guide the activities of the data entry

Mumbai, India

• Worked as drug safety associate in Pharmacovigilance where the adverse reaction(s) of marketed drugs need to be processed and reported to manufacturing company as well as regulatory authority.
• Interpretation of non-serious or serious ADRs of spontaneous and solicited cases following the medical assessment.
• Performing initial checks of adverse event forms of new case in safety database and performing duplicate search of cases.
• Assessing priority to cases using medical judgments.
• Checking the consistency of case against the source document.
• Assessing the validity of cases.

Hyderabad Area, India

• Provider Data Management:
• Demographic Information update.
• Network Information Update
• Group, IPA affiliations updates and maintenanceUpshot: Working with the Apollo gave me concrete foundation for my career. Corporate culture, Business Etiquettes, working in Team, Work forecast, adaptability and result.

M.Pharmacy, Quality Assurance

Masters in Pharmacy specialised in Quality Assurance

Bachelor Of Pharmacy - Bpharm, Pharmacy