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Senior Drug Safety Expert
beBeeMedicineMysuru, Karnataka, India17 days ago
Job descriptionSupport the maintenance of the medical platform, including SOPs, manuals, and documents. Lead and support medical reviewers, interact with clients' medical teams and clinical teams. Action as the main responsible person at PLG for clients' concerns and escalation. Medical review of ICSRs (e.g., Spontaneous, literature), causality, medical assessment, benefit-risk evaluation of medicinal products. Experience in leading medical review teams, client communications, Safety Database experience. Minimum 10 years of experience working for service providers or pharmaceutical companies, at least 5-7 years of experience as a Medical Monitor or Clinical Phase. Microsoft package, Pharmaceutical background – strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety. Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment, Working knowledge of EDC systems. Good medical knowledge and Pharmacology understanding.
Job Title : Medical Advisor
We are seeking a seasoned medical expert to lead our team as a senior medical advisor / reviewer. This role requires proficiency in all aspects of clinical and post-marketing drug safety.
Clinical Phase :
- As a medical monitor / Medical expert, you will work closely with clients, attending investigator meetings and providing support to sites on protocol or possible drug interactions.
- You will review and provide feedback on study protocols, deliver therapeutic area training, and ensure compliance.
- Key responsibilities include drafting medical monitoring plans (MMP), ensuring protocol adherence, reviewing adverse events (AEs), assessing severity, and determining appropriate actions.
- Additionally, you will make assessments on SUSAR reportability, perform review and interpretation of clinical data, ensure protocol compliance, and draft monthly reports for clients.
Post-Marketing (Pharmacovigilance) :
Required Education :
MBBS, or MD (Doctor of Medicine)
Required Experience :
Required Technical Skills :
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Safety Expert • Mysuru, Karnataka, India
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