Senior Medical Expert
We are looking for a seasoned medical professional to lead our clinical and post-marketing drug safety efforts.
Clinical Phase :
- Oversee medical monitoring teams and ensure effective communication with clients, sites, and other stakeholders.
- Develop and implement medical monitoring plans (MMPs) that adhere to GCP and GVP requirements.
- Review adverse events (AEs), assess their severity, and determine appropriate actions.
- Collaborate with the clinical team to develop therapeutic area training materials.
- Ensure compliance with regulatory requirements and provide support for investigator meetings and site queries.
Post-Marketing (Pharmacovigilance) :
Support the maintenance of medical platforms, SOPs, manuals, and documents.Lead and mentor medical reviewers in their work, ensuring they meet client expectations.Interact with clients' medical teams and clinical teams to address concerns and escalate issues as needed.Perform medical review of ICSRs, including spontaneous and literature reports.Conduct causality assessments, benefit-risk evaluations, and provide feedback on cases.Requirements :
MBBS or MD (Doctor of Medicine)Minimum 10 years of experience working in service providers or pharmaceutical companiesAt least 5-7 years of experience as a Medical Monitor or in clinical phasesExcellent technical skills in Microsoft packages and EDC systemsStrong knowledge of GVP, GCP, FDA, and regulatory requirements related to drug safetyKey Responsibilities :
Develop and maintain relationships with clients and sitesCollaborate with cross-functional teams to achieve business objectivesProvide strategic guidance on medical review and pharmacovigilance activitiesWhat We Offer :
Opportunities for growth and developmentA collaborative and dynamic work environmentCompetitive compensation and benefits packageHow to Apply :
Apply now by submitting your application, highlighting your relevant experience and qualifications.