Sreekanth Magikar

• Managed project execution to ensure adherence to budget, schedule, and scope.
• Initiate, review, or approve modifications to project plans.
• Performed risk assessments and developed strategies to handle poor performing employees.
• Coordinated in recruitment or selection of project personnel to help in establishing and balanced team.
• Assess current or future customer needs and priorities through communicating directly with customers, conducting surveys, or other methods.
• Prepare project status reports by collecting, analyzing, and summarizing information and trends.
• Prepare project status reports by collecting, analyzing, and summarizing information and trends.
• Monitor performance of project team members, providing and documenting performance feedback.
• Confer with project personnel to identify and resolve problems.
• Negotiate with project stakeholders or suppliers to obtain resources or materials.
• Assign duties, responsibilities, and spans of authority to project personnel.

• Monitored inflow and outflow of cases and allocating cases to DE associates on daily basis as per priority.
• Preparation of weekly dashboard data, project status report and monthly invoicing reports.
• Lead team in completion of 3000 backlog cases within timelines and required quality without additional resources.
• After receiving monthly client feedback, providing rationales if any, for errors and participating in client quality calls.
• Preparation of quality spread sheets after finalizing feedbacks and sharing and archiving. Monitoring SLA's to be met.
• Follow up with clients regarding outstanding queries and reconciliation of discrepancies.
• Trained, mentored, overseen and guided Drug Safety and Sr. Drug Safety Associates.
• Performs case deletion and nullification of cases, if required.

Quality Reviewer

• Cross verifying information in source document against database after completion of data entry.
• Checking reporter entries, patient, product, event, medical history and lab data coding.
• Checking RSI for Labeled drug-drug or drug-disease interactions, form strength, form of admin and posology, contraindications whether drug is taken as per instructions
  or not, contraindicated drug administered; also checking MedDRA latest version for events so that if up-gradation of case is necessary or not.
• Review Expectedness, case narrative as per conventions. Review follow up letters generated and making necessary corrections as required.
• Providing feedback to associates on case level through mail.
• Document feedback in defect tracker and maintain quality data for each case.
• Conducting quality huddles for DE associates.

Submission:

• Basing on submission guidelines cases will be prioritized and submitted to
  concerned authorities or distributed to partners.
• Maintaining compliance tracker on daily basis.

Data Entry:

• Processing of ICSR's (serious/ non-serious) which include spontaneous, clinical trial and solicited case reports.
• Review coding of following fields medical history, reported adverse events, other reported safety information: eg:- medication errors, pregnancy etc., indication of suspect product and concomitant medications, labs and procedures and cause(s) of death using most appropriate Lower Level Term (LLT) from MedDRA.
• Review coding of suspect drug with company product dictionary (CPD) & review coding of other company suspect drugs, Concomitant, Past and treatment drugs using WHO drug dictionary.
• Generation of follow up letters to be sent to reporters to get additional and clear information regarding reported adverse events.
• Attend training sessions and develop capabilities on ongoing basis.