Medical Advisor (Pharmacovigilance)

We are looking for a Team lead / Manager / senior medical advisor / reviewer proficient in all aspects of clinical and post-marketing drug safety .

Clinical Phase :

Lead as a medical monitor / Medical expert

Medical Monitoring experience is a must and the ability to effectively communicate with the clients, attend investigator meetings as required and provide support to sites regarding protocol or possible drug interactions is essential.

Review and provide feedback on study protocols as needed.

Deliver therapeutic area training for all case processing team.

May require 24 / 7 availability depending on the client needs for possible queries or protocol deviations resulting in potential harm to patients.

Drafting medical monitoring plans (MMP) and ensuring compliance.

Reviewing adverse events (AEs) reported by study sites, assessing their severity, and determining appropriate actions (like dose adjustments or trial discontinuation).

Make assessments on SUSAR reportability.

Perform the review and interpret clinical data, ensure protocol compliance and draft monthly reports for the clients (with presentation at periodic meetings if required).

Develop and update current training materials in line with GCP and GVP requirements for medical review of all cases.

Post-Marketing (Pharmacovigilance) :

Support in maintenance of medical platform including SOPs, manual and documents.

Lead and support the medical reviewers

Interaction with the clients medical team and clinical team

Act as an main responsible person at PLG for clients concerns and escalation

Medical review of the ICSRs (e.g., Spontaneous, literature)

Support in causality, medical assessment, benefit-risk evaluation of the medicinal product.

Mentor junior medical reviewers and perform additional review of cases to ensure competency.

Provide feedback and ongoing workshops to develop the medical reviewers.

Participate in audits and inspections as required

Ensure understanding of client needs, conventions and ensure expectations are met and exceeded

Training and mentoring other team members

Required education : MBBS, or MD (Doctor of Medicine)

Required experience :

Experience in leading medical review teams

Client communications

Safety Database experience

Minimum 10 years experience working for service providers or pharmaceutical company

At least 5-7 years of experience as a Medical Monitor or clinical phase

Required technical skills :

Microsoft package

Pharmaceutical background – strong understanding 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