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Clinical and Pharmacovigilance Lead
2 weeks ago
We are seeking a seasoned Senior Medical Advisor to lead our clinical and pharmacovigilance teams. As a medical professional with a strong track record in drug safety, you will provide expert guidance, review protocols, and develop medical monitoring plans.
Clinical Phase:- Provide medical oversight as a medical monitor, leading investigator meetings, and reviewing study protocols for compliance and quality.
- Develop and implement therapeutic area training for case processing teams, ensuring they have the necessary knowledge to perform their duties effectively.
- Assess adverse events, determine actions, and make assessments on SUSAR reportability, ensuring timely and accurate reporting.
- Interpret clinical data, draft monthly reports, and present findings at periodic meetings, providing valuable insights to inform business decisions.
- Support the maintenance of medical platforms, including SOPs, manuals, and documents, ensuring seamless operations and compliance.
- Lead and support medical reviewers in their work, providing guidance and mentorship to ensure high-quality output.
- Collaborate with clients' medical and clinical teams, fostering strong relationships and ensuring successful project outcomes.
- Act as the main point of contact for client concerns and escalations, providing prompt and effective solutions.
- Perform medical reviews of ICSRs, contributing to causality assessments, medical evaluations, and benefit-risk assessments of medicinal products.
- Mentor junior medical reviewers, performing additional reviews to ensure competency and provide ongoing training and workshops.
- Participate in audits and inspections as required, demonstrating expertise and commitment to excellence.
- MBBS or MD (Doctor of Medicine)
- Minimum 10 years of experience working in service providers or pharmaceutical companies
- At least 5-7 years of experience as a Medical Monitor or in clinical phases
- Strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety
- Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment