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5 ProductLife Group Jobs
VAF 175 Medical Writing Specialist
5-7 years
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
VAF 175 Medical Writing Specialist
ProductLife Group
posted 1d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
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):
- Lead the medical reviewers
- Medical review of the ICSRs (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
MBBS, or MD (Doctor of Medicine)
- 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
- 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
Employment Type: Full Time, Permanent
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What people at ProductLife Group are saying
What ProductLife Group employees are saying about work life
based on 9 employees
Flexible timing
Monday to Friday
No travel
Day Shift
ProductLife Group Benefits
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