Dr. Veeranjaneyulu Nandyala

As Senior Drug Safety Physician

• Performing medical review of lCSR's in pharmacovigilance database (Argus and LSMV) as per the regulations and SOPs across multiple therapeutic areas which include psychiatric, cardiovascular, anti-fungal, contrast media and cell therapy. Ensuring appropriate MedDRA coding of events, seriousness assessment of events, labeling assessment from appropriate labeling documents, causality assessment and ensure medical accuracy of case narratives.
• Review and categorization of Embase literature into valid cases, composite cases and safety information.
• Performing triage assessments for the SAEs received from the site.
• Manage daily workload in conjugation with line manager for individual case processing, literature searches, and any other tasks relevant to the Pharmacovigilance Department.
• Handling of medical queries from client and site and address them appropriately.
• Drafting/preparation, reviewing and updating Safety management plans as per client protocols.
• Generation, preparation and review of SOPs and Wls and execution of company SOPs.
• Maintain awareness of changes to/new regulations affecting PVG activities and train and mentor new employees in PVG if required.
• To carry out necessary administrative duties required for the job.

As Medical Monitor

• Provide medical oversight regarding protocol exemptions, protocol violations, protocol eligibility issues, accepted medications, and general medical-related study issues
• Review laboratory alerts and coordinate appropriate follow-up with study site.
• Conduct training for the project team concerning disease, drug, study design and procedures.
• Provide consultation to the study team during review of out-of-range laboratory values for clinical and /or protocol significance.
• Preview listings of AEs/SAEs, study withdrawal/Discontinuation, lab reports, and subject profiles as defined within the Safety Medical Monitoring Plan.
• Ensure all protocol inquires and answers are documented.
• Preparation of subject narratives, review of study reports and other documents, preparation and/or review of Safety Management Plan, Medical monitoring plan, periodic and interim safety reports
• Monitoring the work progress, ensuring timely delivery, participating in status meetings, and updating project progress to the stakeholders.

• Perform in-depth medical review of individual case safety reports (ICSRs), ensuring appropriate MedDRA coding of events, seriousness assessment of events using EMA-IME list and CTCAE for investigational and marketed products across multiple therapeutic areas (antiepileptic, anticancer, antihistamines and immunology drugs).
• Labeling assessment from appropriate labeling documents, causality assessment, ensure medical accuracy of case narratives and provide medical assessment for high priority ICSRs (mainly ICT-SUSARs, ICT-AESI and Swiss cases, literature/publication studies cases and pregnancy cases).
• Review of source documents to assure medical accuracy of information pertaining to case if required. Device causality assessment of ICSRs and handling of PQC cases (product quality complaints).
• Actively follow up adverse events as and when required to obtain more information and review of all letters and queries for appropriateness and completeness.
• Daily review of Non serious Line listing documents to ascertain seriousness of cases, upgrade potential serious cases and give feedback to case processing team.
• Maintains familiarity with MedDRA, WHO-DRL, and safety databases such as ARGUS, Aris-G and EV Web.
• Works closely with Safety and Pharmacovigilance (SPVG) colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment. Interacts with client's safety/medical personnel as appropriate.
• Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical and post-marketing safety information.
• Maintains medical and pharmacovigilance expertise through appropriate internal or external continued medical education.
• Assists as mentor and trainer for other internal safety staff including case processing staff.
• Performing other duties as assigned by management.

• Handling of casualty, seriously ill patients in both in and out patients departments.
• History taking of patients and handling the responsibility of physical examination of admissions.
• Co-ordination with the emergency team to ensure prompt response to emergencies.
• Examining the patients and deciding on the course of treatment.
• Consulting with other medical professionals about patient care.

• Monitoring and providing general care to patients in hospital wards and out-patient departments.
• Completing procedures necessary for admitting and discharging patients.
• Performing initial diagnosis, drafting reports, and submitting to physicians for review.
• Assisting medical and non-medical staff in the hospital to ensure quality treatment is provided to patients.
• Performing tasks related to the special medical tests of the patients for accurate diagnosis of the disease.
• Assisting to undertake certain managerial responsibilities including planning and distribution of workload for providing quality treatment to patients, staffing the nursing department, and conducting medical tests for appropriate diagnosis.