Lokesh Kumar Email & Phone Number

Mysuru Area, India

RESPONSIBILITIES: Drug Safety Associate (Case Processing): Proficient in case processing of serious adverse events, serious and non serious adverse drug reactions, pregnancy cases from various sources including clinical study, non interventional study, spontaneous case reports and literature case reports.  Responsible for processing of cases from initial data entry of case reports into safety database with capturing the all reported events. Responsible for adverse event and drug coding with MedDRA and WHO DD, safety narrative writing and labeling the all events from reference documents. Responsible for performing the appropriate assessments (including the assessment of seriousness, and company causality for each adverse event) adhering to SOPs/other controlled documents and regulatory requirements.  Responsible for sending queries for clarity associated with incoming information if required and follow ups for serious cases.  Responsible for review of cases, import of cases, sending and reviewing of queries in clinical data management database like i-medidata and RAVE safety gateway. Good knowledge on case processing in ARISg 5.1, 6.0 and 7.1 versions.RESPONSIBILITIES: Drug Safety Associate (Triage): Responsible for case intake from mail box for triage activity and review the source documents to identify type of reports (clinical study, literature, spontaneous and non interventional serious or non serious cases). Responsible for determining validity of the cases based on the validity criteria (Reporter, Patient, Suspect drug, Adverse event)  Responsible for identifying duplicate ICSRs, initiation and triage of cases. Assessing the seriousness of the case so that company, Sponsor and regulatory timelines are met for the processing and reporting of safety information. Good knowledge in performing initiation and triage activities in ARISg [5.1, 6.0 and 7.1 versions] and AgXchange – [IRT 6.0, 7.1 versions].

RESPONSIBILITIES: Drug Safety Associate (Case Processing): Proficient in case processing of serious adverse events, serious and non serious adverse drug reactions, pregnancy cases from various sources including clinical study, non interventional study, spontaneous case reports and literature case reports.  Responsible for processing of cases from initial data entry of case reports into safety database with capturing the all reported events. Responsible for adverse event and drug coding with MedDRA and WHO DD, safety narrative writing and labeling the all events from reference documents. Responsible for performing the appropriate assessments (including the assessment of seriousness, and company causality for each adverse event) adhering to SOPs/other controlled documents and regulatory requirements.  Responsible for sending queries for clarity associated with incoming information if required and follow ups for serious cases.  Responsible for review of cases, import of cases, sending and reviewing of queries in clinical data management database like i-medidata and RAVE safety gateway. Good knowledge on case processing in ARISg 5.1, 6.0 and 7.1 versions.RESPONSIBILITIES: Drug Safety Associate (Triage): Responsible for case intake from mail box for triage activity and review the source documents to identify type of reports (clinical study, literature, spontaneous and non interventional serious or non serious cases). Responsible for determining validity of the cases based on the validity criteria (Reporter, Patient, Suspect drug, Adverse event)  Responsible for identifying duplicate ICSRs, initiation and triage of cases. Assessing the seriousness of the case so that company, Sponsor and regulatory timelines are met for the processing and reporting of safety information. Good knowledge in performing initiation and triage activities in ARISg [5.1, 6.0 and 7.1 versions] and AgXchange –[IRT 6.0, 7.1 versions].

As a triage performing member in ARISg and IRT.As a case processing member in ARISgAs a quality reviewer.

Masters In Pharmacy, Pharmacology

Bachelor Of Pharmacy (B.Pharm.)

Ssc