Company Description
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.
We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.
For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).
‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency
Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.
Job Description
We are seeking a highly skilled and experienced Medical Monitor to join our clinical research team in Hyderabad, India. As a Medical Monitor, you will play a crucial role in ensuring the safety and integrity of our clinical trials, providing medical expertise throughout the study lifecycle.
- Oversee the medical aspects of clinical trials, including protocol development, study conduct, and data interpretation
- Review and assess safety data, adverse events, and serious adverse events in ongoing clinical trials
- Provide medical expertise in the development and review of study protocols, informed consent forms, and clinical study reports
Advise project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
Collaborate with cross-functional teams to address medical and safety issues arising during clinical trials
Identify Program risks, and create and implement mitigation strategies with Clinical Operations
- Participate in the development of risk management plans and safety monitoring strategies
- Conduct medical review of clinical data and contribute to the preparation of clinical study reports
- Serve as a medical resource for study teams, investigators, and other stakeholders
- Ensure compliance with ICH-GCP guidelines, regulatory requirements, and internal SOPs
- Contribute to the development of investigator brochures and other clinical documents
- Represent the company in interactions with regulatory authorities and ethics committees as needed
Qualifications
Qualifications and experience
- MBBS, MD (Pharmacology)
- Minimum 3 years of experience as Medical Monitor
Job role requirements
- Thorough understanding of ICH-GCP guidelines and regulatory requirements in clinical research
- Proven experience in conducting and/or monitoring clinical trials
- Strong knowledge of the drug development process
- Excellent skills in medical data analysis and interpretation
- Proficiency in protocol development and review
- Experience in adverse event assessment and management
- Strong medical writing skills for creating and reviewing clinical documents
- Proficiency in using clinical trial management systems
- Outstanding communication and interpersonal skills, with the ability to interact effectively with diverse stakeholders
- Detail-oriented with strong analytical and problem-solving abilities
- Ability to work efficiently in a fast-paced, dynamic environment
- Willingness to travel as required for the role
