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Adverse Event Monitoring: Collecting, reviewing, and analyzing reports of adverse drug reactions from clinical trials and post-marketing sources to identify potential risks
Regulatory Compliance: Ensuring all drug safety activities adhere to global regulatory guidelines, including FDA, EMA, and other health authorities
Data Analysis and Reporting: Preparing detailed safety reports, documenting case reviews, and communicating findings to regulatory authorities, healthcare professionals, and internal teams
Risk Management: Contributing to the development and execution of risk management plans to mitigate potential drug-related hazards
Clinical Trial Oversight: Monitoring patient safety during trials, ensuring adherence to protocols, and reporting adverse effects promptly
Bachelor of Dental Surgery (B.D.S), Bachelor of Homeopathic Medicine and Surgery (BHMS), Bachelor Of Pharmacy (B.Pharm), Bachelor of Ayurvedic Medicine and Surgery (BAMS), Doctor of Pharmacy (PharmD), Master of Pharmacy (M.Pharm), Bachelor of Science (B.Sc)
At Kingston Healthcare, we envision a robust healthcare ecosystem where trained professionals seamlessly integrate into progressive companies, driving innovation and excellence in Clinical Research. We aim to be the leading training institute recognized for our commitment to quality education, strong industry partnerships, and our relentless pursuit of student success.
Job ID: 152208471
Skills:
MedDRA coding, Pharmacovigilance, Drug safety surveillance, Case processing, Data Entry