Senior Drug Safety Physician with over 7 years of pharmacovigilance and 3 years of clinical experience.
Periodic Benefit Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs); Periodic Adverse Drug Experience Reports (PADERs); Addendum to Clinical Overview (ACOs); Health Hazard Evaluations (HHEs)
Experienced in Case Analysis for Ad Hoc reports and Surveillance Analysis of Non Spontaneous Safety Data for PharmacoVigilance (SNAP)
Experienced in conducting medical review of PBRERs/PSURs, PADERs, HHEs, Ad Hoc Reports, SNAP and Safety Management Team (SMT) Slides which includes checking the case for overall medical cohesiveness, checking the expectedness of adverse events, adding company causality and company comments
Trained in Monthly Signal Reports and Drug Abuse Report for FDA
Maintaining a knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, aggregate reporting conventions and guidelines, clients’ procedures and international drug safety regulations. Maintaining an awareness of global regulatory reporting obligations.
Experienced in conducting medical review of PBRERs/PSURs, which includes checking the case for overall medical cohesiveness, checking the expectedness of adverse events, adding company causality and company comments.
KULDEEP KINJA, completed his Bachelor of Pharmacy from M.D University, Rohtak after which he completed his Master in Pharmacy with Pharmacology from NIMS University, Jaipur.
He started his career with Wipro Ltd as Pharmacovigilance Officer in Drug Safety Department. He is having more than 8 years of industry experience in different Pharmacovigilance processes with global companies. He has expertise in end to end Pharmacovigilance processes, trainings, operations and people management such as collecting, handling and processing Individual case safety reports (ICSRs) in different safety databases like Argus, SafetyEasy along with MedDRA coding and narrative writing, aggregate reporting, signal detection, risk management plans, talent acquisition& backfill, maintenance of training files, liasoning for client training, preparation & maintenance of training plan & requisite material, Client & Business Reviews, Internal & External Audits, SOP (Standard Operating Procedure) & BCP (Business Continuity Plan) Management, Client Reverts & Observation Handling, deviation handling &CAPA (Corrective & Preventive Actions) closures, Bottom Quartile Management (BQM), Quality Initiatives, Reconciliation Reports & Invoicing, Calculation & Maintenance of CPMs (Critical Process Metrics), Shift & Roster Management, Attrition Management, Quality Initiatives, Lean and CI projects, preparing and reviewing documents like QMP, SOPs, WI, DMP etc in Pharmacovigilance, imparting training and preparing training materials, audits and inspections (readiness, handling and post audit/inspection response completions), regulatory guidelines, pre-sales and client mining.
He is currently working with Tenet Health Edutech Pvt. Ltd. as Pharmacovigilance Trainer and Consultant and his key responsibilities includes developing modules and training material on pharmacovigilance as per the ever evolving changes in regulatory and industry guidelines, delivering end to end pharmacovigilance training, participating in business development activities related to any opportunities in pharmacovigilance domain.
Mr. Amit is an energetic professional with sound academic background in Bachelor of Pharmacy and Post Graduate Diploma in Clinical Research. He is a highly motivated, efficient Lean Six Sigma Green Belt certified professional with a total 14 years of work experience in life sciences domain.
Mr. Nakhe has hands on experience of new process start up, transition and process improvement projects. He also has successfully faced both external and internal audits and inspections (MPA, MHRA and USFDA) on various occasions.
He possess excellent communication and collaboration skills to lead and the ability to work in diverse groups effectively. He has performed roles like Process Executive and team lead.
He is currently working as a Faculty at CLINIMINDS (Institute of Health Sciences Training & Management) and is responsible for developing and updating training modules and content for Clinical research &pharmacovigilance, Delivering training programs etc.
Mr. Amit has been associated with Watson Pharma Pvt. Ltd. & Macleod’s Pharmaceuticals as a CRA and was responsible for coordinating clinical studies in CRO units.
He also worked for Tata Consultancy Services for approximately 10 years, managing large teams in Life Sciences Division with hands on experience in Pharmacovigilance/Patient Safety for 2 big pharma clients. He has worked on Sapphire (Patient safety database) and Argus.