Thrishul Pendyala Email & Phone Number

Having Clinical professional with experience almost close to 10 years in the field of Pharmacovigilance.• Completion of case processing (Case data entry, labeling, approval numbers, product quality complaints, manual coding, narrative writing).• Handled Spontaneous cases, pregnancy cases, overdose cases Prepared ADRs forms and closed the case satisfactorily.• Being a key player in the team, taken part in conducting product information presentations, quality huddles, case distribution and sharing the updates to the team members.• Prioritization of the cases depending on their contractual and regulatory timelines.• Mentoring newly joined associates in Quality review.• Preparing MOMs, Deviation Memo and Query resolutions.• Use of MedDRA to code medical history and adverse event terms.• Discuss source documents, coding conventions and ad-hoc queries with Pharmacovigilance Physician.• Remarkable knowledge of scientific terms and medical terminology.• Basic understanding of international regulations proficient in data entry and drug safety database. • Implement and support operational decisions as determined and instructed by senior management. • In contribution and assist in global initiatives e.g. Subject Matter Expert (SME) Committees, SOP Review Committees.• Thorough understanding of project deliverables and scope of work (SOW) for assigned projects and maintain documentation as appropriate. • Handling of correction version analysis and conducting retraining’s and refresher session for concerned associates.• Ensured compliance to updation of relevant quality, productivity and compliance trackers and processes including communications -Address to correct person, timely response, escalate in right time.• Process related experience in different kinds of cases like Legal, Spontaneous, Solicited, Product quality complaints, Literature, non-interventional clinical trial and pregnancy cases etc.Class of drugs Handled:Anti diabetics/Anti cancer/Anti platelets/Anti coagulants/Anti psychotics/Antibiotics/Anti inflammatory/Anti hypertensive drugs.

Listed skills include Validation, Regulatory Affairs, Hplc, Pharmaceutical Industry, and 3 others.