Anald Thomas Email & Phone Number

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Involved in the conduction of medical and scientific review of AE/ADR reports originating from clinical trials, post-market, literature and other potential sources. Providing regulatory assessment of the cases for expedited reporting in various jurisdictions. Leading Signal Detection and Risk Management activities. Developed the signal detection application for visualization, analysis and preparation of the periodic signal detection reports. Conduct periodic review of safety data from clinical trials. Performing review of medical coding of adverse events. Writing assigned aggregate safety reports (PSUR, DSUR, annual IND) and safety section of Investigator’s Brochure and other scientific or regulatory documents for investigational and marketed products. Lead and successfully completed a variation that was accepted by the EMA leading to a significant reduction in the burden on patients for a specialty orphan product. Contribute to generation and review of SODs related to Medical Safety and Medical Information. Conduct literature reviews on products developed or under development by ApoPharma and when assigned, consult with academic experts on medical matters related to safety of the ApoPharma products. Respond to requests for safety information from regulatory authorities or third-parties worldwide. This role in Canada has provided me with an enhanced knowledge of the end to end processes involved in life-cycle of a product from its development, ongoing clinical trials, post-marketing commitments and constant interaction with health authorities (Health Canada, EMA and FDA) leading to a better understanding of the regulatory requirements and the responsibilities of a pharmaceutical company working within this complex environment.

Bengaluru Area, India

Involved in leading the Medical evaluation team, responsible for the overall medical evaluation of ICSRs and Aggregate reports of multiple clients including the EMA, along with handling the client interaction, people, performance and project management of the Pharmacovigilance service line. Engaged in Business Development activities, including, Leading the Labelling hub, member of the Global Safety and Labelling Committee, and India Leadership Team in Kinapse, responsible for the strategic leadership and vision of this global company with primary offices in the United Kingdom.

Bengaluru Area, India

Involved in leading the Medical evaluation team, responsible for the overall medical evaluation of ICSRs and Aggregate reports of multiple clients including the EMA, along with handling the client interaction, people, performance and project management of the Pharmacovigilance service line. Engaged in Business Development activities, including, Leading the Labelling hub, member of the Global Safety and Labelling Committee, and India Leadership Team in Kinapse, responsible for the strategic leadership and vision of this global company with primary offices in the United Kingdom.

Bengaluru Area, India

Involved in leading the Medical evaluation team, responsible for the overall medical evaluation of ICSRs and Aggregate reports of multiple clients including the EMA, along with handling the client interaction, people, performance and project management of the Pharmacovigilance service line. Engaged in Business Development activities, including, Leading the Labelling hub, member of the Global Safety and Labelling Committee, and India Leadership Team in Kinapse, responsible for the strategic leadership and vision of this global company with primary offices in the United Kingdom.

Chennai Area, India

Process Lead - Leading the Aggregate reporting project for Novartis Pharma, responsible for the overall project management, quality control, client interaction, product delivery and successful completion of the pilot project and its subsequent contract expansion.

Chennai Area, India

Team lead in the Aggregate reporting project for Bristol-Myers-Squibb responsible for the overall management of the evening team, including work allotment, project/document management, quality, client interaction/relationship, and individual performance of team members. Also contributing as the Lead Physician in more complex periodic safety reports including PSUR, PADER, PBRER, HA assessment reports/responses, PRAC assessment reports/responses, Risk Management Protocol (RMP) etc., with similar activities as mentioned below for a top level global pharmaceutical company, working on CARES and CARA PRISM database.

Chennai Area, India

Aggregate Safety Reporting (ASR) Physician, as a permanent employee, contributing as the Lead Physician in a variety of periodic safety reports including PSUR, PADER, PBRER, HA assessment reports/responses, PRAC assessment reports/responses, Risk Management Protocol (RMP) etc., for Bristol-Myers-Squibb, working on CARES and CARA PRISM database. This role involves providing Medical review and assessment of Aggregate and individual cases, preparation of benefit risk assessments with in-depth knowledge of FDA and EMEA regulations, response to Health Authority assessment reports (PRAC Assessments), analysis/evaluation of safety signals etc., in all therapeutic areas. Was also involved in a pilot project aimed at the detection and analysis of safety signals during this period.

Chennai Area, India

Medical reviewer, working as a contract employee involved in the pharmacovigilance of ICSR (Individual case safety report) cases with a worldwide exposure for PFIZER working on ARGUS database.

Kerala, India.

Had an active private clinical practice as a General Physician in Sneha Hospital, Kerala for 3 years involved in the care of patients with a wide range of acute and chronic disorders and was also involved in organising vaccination programs for a number of software and pharmaceutical companies like Shell, Sanofi Pasteur in association with Vaccine World, Chennai.

Reno, Nevada Area

Observership under the following US doctors and specialties mentioned to gain US Clinical experience relevant for application for residency in USA. Dr. Timothy J. Louie, M.D (Neurology) Dr. Robert F. Quigley, D.O (Nephrology) Dr. Robert D. Swackhamer, M.D.,F.A.C.C (Cardiology) Dr. Thomas S. DaVee, M.D.,F.A.C.C (Cardiology) Dr. Charles M. Carpenter, M.D.,F.A.C.S (General surgery).

Chennai Area, India

Duty Medical officer involved in the care of patients both in the wards and outpatient departments.

Chennai Area, India

Duty Medical officer involved in the care of critically ill patients ranging from acute Ml, acute respiratory failure, renal failure to a wide range of other medical conditions requiring critical care as well as post-surgical patients who required intensive care and monitoring following open abdominal surgeries, laparoscopic procedures, head and neck surgeries, CABG, hysterectomy and a host of other major and minor procedures.

Chennai Area, India

Initial private clinical practice as a General Physician dealing with non critical patients with a wide range of non serious acute and chronic medical disorders in an outpatient setting.

Bengaluru Area, India

Rotated through all compulsory departments in a 1200 bed tertiary care hospital. This Medical college is rated as one among the top five medical colleges in India consistently.