Clinical Drug Safety Expert

We are seeking a seasoned Medical Team Lead to oversee the development and execution of our clinical and post-marketing drug safety initiatives. The ideal candidate will possess expertise in all aspects of medical monitoring, including leading as a medical monitor / medical expert, reviewing and providing feedback on study protocols, delivering therapeutic area training for case processing teams, and drafting medical monitoring plans (MMP).

• The selected individual will be responsible for managing medical review teams, interacting with clients' medical teams and clinical teams, and acting as the main point of contact for client concerns and escalations.
• They will also be tasked with mentoring junior medical reviewers, performing additional reviews of cases to ensure competency, and providing ongoing workshops to develop medical reviewers.

Key responsibilities include :

Required education includes an MBBS or MD degree, while required experience involves at least 10 years of experience working for service providers or pharmaceutical companies, with 5-7 years of experience as a Medical Monitor or clinical phase.

Technical skills include proficiency in Microsoft packages, a strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety, deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment, as well as working knowledge of EDC systems.

Additional qualifications include good medical knowledge and pharmacology understanding, along with excellent communication and interpersonal skills.

This is a unique opportunity to lead a team of medical professionals in shaping the future of drug safety initiatives.