DINESH RACHAGOLLA

• As a Study Manager and Study Lead, I manage client meetings and requirements, team tasks, KOM, and workflow management on a regular basis
• Monthly SAE/DD listings, Compliance reports, Safety Reconciliation reports, Study workflow metric reports
• Reviewed adverse event reports to ensure accuracy and completeness of data collected
• Prepared periodic safety update reports and other documents related to regulatory submissions
• Collaborated with medical directors, clinical research associates, and regulatory affairs personnel to ensure compliance with applicable regulations and guidelines
• Provided technical support during internal audits or inspections by health authorities
• Generated metrics to measure performance of pharmacovigilance processes within the organization
• Created and maintained standard operating procedures for pharmacovigilance activities
• Developed training materials on drug safety topics for internal use by employees
• Researched emerging trends in pharmacovigilance practices and shared findings with colleagues
• Maintained a database of adverse events received from various sources including spontaneous reporting systems
• Argus Safety database, MedDRA and WHO-DD, Narrative writing, Client meeting and Minutes of meeting, DSMB Meetings, Medical Device and Drug case processing.
• Collected, arranged, and input information into database system.
• Cross-trained existing employees to maximize team agility and performance.
• Accomplished multiple tasks within established timeframes.

As a case intake member: I am responsible for case intake, duplicate checks, and registration

• Maintaining source documentation and other communication
• As a case processor: Responsible for data entry of individual case safety reports (literature cases) into the safety database
• Review and evaluate AE case information to determine required action based on and following internal policies and procedure
• Process all incoming cases to meet the timeline
• Full data entry including medical coding and safety narrative
• As a medical coder: Responsible for coding all medical history (events, procedure, suspected drugs from the article, indication, lab tests as per dictionary (MedDRA and WHO-DD)
• As a narrative writer: I am responsible for writing medically relevant safety narratives of cases and checking the competence and accuracy of the data entered in various fields
• As a quality check reviewer: Performing quality check of cases against the source document articles including the coding of events, coding of suspect, co-suspect, and concomitant medications
• Case assignment and related activities
• Handling site-related queries
• I was involved in various refresher training programs to train new employees in non-Argus and drug-specific conventions.

• Handled projects on Systematic literature reviews (HIV, Hepatitis C, HIV and Diabetes Triple Therapy) and Social Network Analysis
• Abstracts writing, Manuscript writing, Poster presentations at international conference, Journal clubs and discussions on new topics (like patient journey).