
Chief Medical Advisor
4 days ago
Medical Leadership Opportunity
We are seeking a seasoned medical professional to lead our medical review teams and provide expertise in clinical and post-marketing drug safety.
Clinical Phase Responsibilities:
- As a medical monitor/medical expert, you will be responsible for reviewing study protocols and providing feedback as needed.
- Deliver therapeutic area training for case processing team members.
- Develop and update current training materials in line with GCP and GVP requirements.
- Review and interpret clinical data, ensuring protocol compliance and drafting monthly reports for clients.
- Assess the reportability of SUSARs and perform the review of adverse events (AEs) reported by study sites.
Post-Marketing (Pharmacovigilance) Responsibilities:
- Support the maintenance of our medical platform, including SOPs, manuals, and documents.
- Lead and support medical reviewers, interacting with clients' medical teams and clinical teams.
- Act as the main point of contact at PLG for clients' concerns and escalation.
- Mentor junior medical reviewers and perform additional reviews of cases to ensure competency.
- Provide ongoing feedback and workshops to develop medical reviewers.
- Participate in audits and inspections as required.
Requirements:
- A MBBS or MD degree.
- Experience in leading medical review teams, client communications, safety database experience, and regulatory requirements related to drug safety.
- A minimum of 10 years of experience working for service providers or pharmaceutical companies.
- At least 5-7 years of experience as a Medical Monitor or in the clinical phase.
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