Ashish Gakkhar

Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

• Responsible for management of Individual Case Safety Reports (ICSRs) including Triage of ICSRs/POP/Literature screening within timelines required to be submitted to the regulatory authorities.
• Review of ICSRs including determining the expectedness of adverse events against various labeling documents (such as EMC, CDS, IB etc.).
• Writing case narratives, assessing causalities, and writing company comment.
• Maintaining a good working knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, client's procedures, and international drug safety regulations.
• Maintaining good knowledge of Case processing conventions and guidelines, labelling documents and international drug safety regulations.
• Global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines.
• Offered friendly and efficient service to client.
• Performed coding and recoding of study ID, Protocol ID, suspect product, and adverse event.
• Handling Compliance related activities to ensure deliverable within KPI and HA timelines for vendor.
• Trained more than 40 new users in the team.

• Experienced in processing and quality check of pregnancy cases.
• Involved in multiple special projects including legacy transfers.
• Involved in other MAH reporting activity to report the SAE caused by drug to the respective MAH.
• Involved in Quality management to provide first time quality assurance to client.
• Involved in Quarterly and annual client audits.

• Watching documentaries on medical advancements
• Listening to music
• Cooking