Rishab Sharma Email & Phone Number

New Delhi, Delhi, India

Mysore, Karnataka, India

• Data Entry:• Enter case data, including but not limited to General information, Reporter details, Patient details, Event details, seriousness, reported causality (when appropriate), medical history, and laboratory data as provided by the reporter. Use MedDRA to code information like specified events, medical history, laboratory data, as applicable, as provided by the reporter.• Code products specified as suspect or concomitant by the reporter using Company Drug Dictionary/WHO Drug Dictionary as needed, provide additional details as needed• Enter the narrative, as required, use a lead sentence as appropriate• Self-review AE report data for completeness and verify certain fields to determine as critical (including but not limited to reportability) as well as conformity to E2B standards after completion of data entry.• Initiate follow-up activities to obtain additional information and clarification, as appropriate.• Forward cases for case review or invalid workflow in the global safety database.• Peer Review:• Perform Peer review of all processed cases, prioritizing Peer review of cases in ARGUS database based on the case types.• Review and evaluate AE case information to determine required action based on and followinginternal policies and procedures. Evaluate accuracy, consistency, and completeness of report(s) against the process.• Ensure completeness of event term selection, MedDRA coding, verbatim narrative, and other relevant fields as per the quality control tracker• Track and document observations and recommendations.• Communicate with the team to ensure quality recommendations are clear.• Perform Consistency Check of all processed cases.

Mumbai, Maharashtra, India

• Monitoring of drug safety mailbox.• Preparation of company core datasheets• Updation of Products and Licenses in the safety database.• Safety data exchange agreement maintenance.• Reconciliation with Business Partners, Distributors, RBMs, Country Managers, andother vendors.• Acknowledging and acting on emails with Ipca Regulatory team.

India

• Working Knowledge of Clinical Trial Process, ICH-GCP, Budget Preparation, Site Initiation, and Site management activities ensuring Regulatory, ICH-GCP, and protocolCompliance.• ICF Designing, SOP Designing, CRF Designing, Data Cleaning, and Data Review Activities• Secondary Research, Review paper Writing, Protocol Designing.• Audio-Video recording of ICD process, Logistic Subject Follow-up• Antibiotic stewardship• Surgical prophylaxis• Data collection and data review.

Yamunanagar, Haryana

•Increase product awareness, answer queries and provide advice.• Introduce new products.• Maintain a relationship with the customers.• Monitoring competitor and product activity.• The main responsibility is to track product availability assigned territory.

Master Of Business Administration - Mba, Operations Management

Post Graduation Diploma In Pharmacovigilance And Cdm, Clinical Research And Pharmacovigilance

Bachelor Of Pharmacy - Bpharm, Pharmacy