01Responsibilities
Clinical Phase:
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.
Interaction with the clients medical team and clinical team
Medical review of the ICSRs (e.g., Spontaneous, literature)
Support in causality, medical assessment, benefit-risk evaluation of the medicinal product.
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
Required Education:
MBBS, or MD (Doctor of Medicine)
Required Experience:
Client communications
Safety Database experience
Minimum 5 years experience working for service providers or pharmaceutical company.
Required technical skills:
Microsoft package
Pharmaceutical background solid 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
Valuable Medical knowledge and Pharmacology understanding
Additional experience and/or skills:
Effective communications skills both written and verbal to be able to explain complex concepts and address queries from the team.
Experience with DSMB preferred.
Ability to deliver constructive feedback
Emotional intelligence
Adaptability
Analytical skills
Flexibility
Reliable
Solid organisation skills
Punctual
Database experience .
