Suraj Wakode

Experience

1. Drug Safety Associate

   Qinecsa Solutions

   Jan 2022 — Present

   Perform end-to-end processing of individual literature safety cases, ensuring accurate and timely data entry into the global safety database in line with client timelines and priorities. Consistently meet SLA requirements through effective workload prioritization and quality control-Review, evaluate, and validate adverse event case information for accuracy, completeness, and regulatory compliance, including assessment of seriousness, reportability, and conformity to E2B standards. Ensure critical fields are verified prior to case submission.Execute medical coding of adverse events, medical history, drugs, indications, procedures, and laboratory data using MedDRA, WHO-DD, and company product dictionaries. Maintain consistency and regulatory accuracy across all coded data-Manage case intake activities including email intake, duplicate check, case registration, and source document logging within the safety database. Conduct triage and validity assessments to determine reportable safety cases-Prepare clear, concise, and medically relevant safety narratives that accurately summarize clinical information, event chronology, and reporter details. Ensure narratives align with regulatory expectations and internal quality standards-Initiate and manage follow-up activities with reporters, authors, and license partners to obtain missing or clarifying information. Track responses and update cases to maintain data integrity and completeness.Generate and manage query action items such as split case requests, discrepancy clarifications, and non-assessed license partner letters. Ensure appropriate routing and closure of queries within defined timelines- Act as a subject matter contributor by sharing pharmacovigilance knowledge across teams and supporting multidisciplinary workflows. Participate in discussions where domain expertise is required to address evolving client or operational needs.

Education

• Government College of Pharmacy Chatrapati Sambhaji Nagar (Aurangabad)

  Master's degree, Pharmacy

• School of Pharmacy Swami Ramanand tirth Marathwda University Nanded

  Bachelor's degree, Pharmaceutical Sciences