Dr.Phani Kumar Email & Phone Number

Chennai, Tamil Nadu, India

Chennai Area, India

Mysuru Area, India

As Case intake member:*Responsible for Email intake, case intake, duplicate check, and registration of the case in to the safety data base.*Maintain log of source documents and other communications.*Determine the validity of the case and complete the triage process.As Case processor:*Responsible for data entry of individual case safety reports into the safety data base.*Review and evaluate AE case information to determine validity of a case, seriousness and expeditedness as per client and internal policies and procedures.*Process all incoming cases in order to meet timelines.*Full data entry including medical coding and safety narrative.As Medical coder:*Responsible for coding all medical history, events, drugs/procedures/indications and laboratory tests according to the appropriate dictionary (For e.g: MedDRA, company product dictionary, DRL code).As Narrative writer:*Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.Other Responsibilities:*High level proficiency at all workflow tasks.*Perform any other drug safety related activities as assigned.*Follow departmental AE workflow procedures.*Follow up on reconciliation of discrepancies.Specialized knowledge and skills:*Very good competency with medical and therapeutic terminologies.*Ability to work independently but guided by documented procedures, with appropriate support.*Able to work effectively as part of a team.*Understanding of principles of all PV regulatory obligations.*Familiar with regulatory and pharmacovigilance guidelines.*Familiar with pharmacovigilance terminology.*Ability to deliver within established timelines.*Fluency in English and excellent comprehension.*Relevant product and industry knowledge.*Experience with relevant software applications.

Doctor Of Pharmacy (Pharm.D.), Pharmacy

Diploma In Pharmacy, Pharmacy