Dr. Reddy’s Laboratories
Role Name: Dr. Reddy’s Laboratories, Medical Monitoring Team: Global Medical Affairs
Locations: Corporate office, Banajara Hills Reporting to: Head of Clinical operations
About Dr. Reddy’s Laboratories
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infective. Major markets include India, USA, Russia-CIS and Europe apart from other select geographies within Emerging Markets. For more information, log on to: www.drreddys.com
To facilitate the process of specific clinical studies adhering to the protocols of safety with the objective of ensuring the safety of the patient
- Review of patient eligibility. In case of discrepancy, flag the case & take necessary actions.
- Discuss the case within the team & the investigator, deciding on if to go ahead with the patient or not.
- Review protocol deviations and communicate decisions to site regarding these deviations.
- Respond on the clarification on the queries of the doctor in order to facilitate the clinical study in practice & smooth handling of queries.
- Review any out of range or “panic” laboratory test results .When applicable, communicate with site coordinator / site investigator to discuss significant abnormal test results and initiate appropriate actions in accordance with study protocol and patient safety.
- In case of any serious adverse events, provide medical inputs & collect the data.
- Follow up on collating the data on series of formats to be captured from the doctors in case of a serious adverse event. Share the same with Pharmacovigelence team for further steps.
- Review the protocols, CRF, ICF on a periodic basis. Review & provide necessary inputs for designing the Monitoring Manual (frequent need basis )
- Operating Network
Internal: Team Member Pharmacovigilence, Team Member Medical writing, Team Member Data Management, TM Regulatory team, Clinical Research Associate, Team Member Formulation team, Medico-marketing team
External: Site Investigators, CRO
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