Errojula Avinash

About Errojula Avinash

As a pharmacovigilance professional, I specialize in drafting aggregate reports like PBRER, PSURs, RMPs, and PADERs, ensuring high-quality standards and timely submissions. My responsibilities include generating and reviewing safety report line listings, performing literature reviews, and summarizing findings for safety evaluations and product renewals.I handle case processing, including spontaneous and literature 15-day cases, triage, adverse event notifications, and complete case creation in the PV Safety Database. My tasks also involve document redaction, data entry, and drafting narratives. I stay updated on relevant regulations and contribute to process improvements.

Experience

1. Junior Drug Safety Associate

   Jeevan Scientific Technology Limited

   Jun 2024 — Present · Hyderabad, IN

   To author/draft aggregate reports like PBRER/PSURs, RMPs, PADERs and signal reports and also calendar/scheduling, timeline and quality. • Responsible for generating and reviewing Aggregate Safety Report Line listings.• Perform literature review and summary of literature for aggregate reporting, epidemiology, product renewals and safety evaluations.• Create all documents in accordance to all applicable SOPs, and convention of the client. Plan, organize, and manage daily work to meet service level timelines and deliverables.• Provide word and PDF versions of the final signed documents to the client.• Participate in internal and external audits and inspections by clients and health authorities.• Keeping updated on relevant regulations associated with the above activities. Contributes to initiatives for process improvement and cross-product process consistency.• Ensure a smooth coordination of the aggregate safety report writing process and a timely submission to the US FDA.• Responsible for signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterization of risks.• Responsible for literature deliverables for aggregate reports and/or signal management activities.• Responsible for monitor of health authority safety alerts, maintain & update of trackers.• Responsible for archiving of aggregate reports and supported source documents.• Act as mentor for new employees.• Any other duties assigned by Line manager.

Education

• Jawaharlal Nehru Technological University

  Bachelor of Pharmacy, Pharmaceutical Sciences

  2019 — 2023