Medical Advisor

4 weeks ago

India ProductLife Group Full time

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

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