Experienced Medical Advisor Wanted

We are seeking an experienced Medical Advisor to join our team. As a Medical Advisor, you will be responsible for leading medical review teams and ensuring the highest level of drug safety.

In this role, you will work closely with our clients to provide expert guidance on clinical and post-marketing drug safety. You will lead as a medical monitor, reviewing and providing feedback on study protocols, delivering therapeutic area training for case processing teams, and drafting medical monitoring plans.

Clinical Phase responsibilities include :

• Leading as a medical monitor
• Reviewing and providing feedback on study protocols as needed
• Drafting medical monitoring plans (MMP) and ensuring compliance
• Reviewing adverse events (AEs) reported by study sites, assessing their severity, and determining appropriate actions
• Making assessments on SUSAR reportability
• Performing the review and interpreting clinical data, ensuring protocol compliance and drafting monthly reports for clients

Post-Marketing (Pharmacovigilance) responsibilities include :

• Supporting in maintenance of medical platform including SOPs, manual and documents
• Leading and supporting the medical reviewers
• Interacting with the clients medical team and clinical team
• Acting as the main responsible person at PLG for clients concerns and escalation
• Medical review of the ICSRs (e.g., Spontaneous, literature)
• Supporting in causality, medical assessment, benefit-risk evaluation of the medicinal product
• Mentoring junior medical reviewers and performing additional review of cases to ensure competency
• Providing feedback and ongoing workshops to develop the medical reviewers
• Participating in audits and inspections as required
• Ensuring understanding of client needs, conventions and ensuring expectations are met and exceeded
• Training and mentoring other team members
• Required Skills and Qualifications :

To be successful in this role, you will need :

Experience in leading medical review teams

Strong communication skills

Knowledge 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

• Benefits :

This is an exciting opportunity to work with a dynamic team and contribute to the success of our organization. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

• What We Offer :

We offer a collaborative and supportive work environment, with opportunities for professional growth and development. Our team is passionate about delivering high-quality results and making a positive impact.