Randstad Enterprise
Website:
randstadenterprise.com
Job details:
Job Title: Associate Director || Senior Manager, Triage and Medical Review Team Lead
- Location: Onsite: Hyderabad
- Experience level: 8-20 Years
Position Summary
The Associate Director & Senior Manager, Triage and Medical Review Team Lead oversees the complete triage and medical review of Individual Case Safety Reports (ICSRs) from global development programs and certain globally marketed products, as part of the India-based Global Patient Safety (GPS) POD. This role is responsible for overseeing end-to-end case quality to ensure accurate coding and expectedness determination through causality assessment and company comment, confirming each case is inspection-ready prior to health authority submission. The role works in close collaboration with the triage team and global GPS partners to produce cohesive, scientifically sound case triage and documentation.
Essential Job Duties
- Medical Review Oversight: Oversee complete medical review of ICSRs, ensuring all relevant and medically important information is accurately captured in Argus.
- Team Leadership: Oversee the lead of the Triage team and ensure harmonization of triage and medical review activities.
- Narrative & Causality: Oversee the review and updating of case narratives, author analysis of similar events (where applicable), and provide company causality rationale to ensure outputs are clinically accurate and aligned with reporting decisions.
- Expectedness Determination: Provide guidance and oversight on expectedness determinations with precision, ensuring alignment with assigned development programs, marketed products, and current approved labeling (IB, USPI, SmPC).
- MedDRA Coding: Oversee MedDRA coding of adverse events and medical history; ensure coding is clinically appropriate and consistent with GPS standards.
- Cross-Functional Collaboration: Lead collaboration across PV teams, Risk Management leads, and clinical development leads to produce cohesive, comprehensive case documentation prior to regulatory submission.
- Medical Expertise: Serve as the medical resource for assigned compounds within the GPS POD; manage and resolve case-level issues, escalating when complexity warrants.
- Process Improvement: Oversee and contribute where needed on SOP development, process improvement, and inspection readiness activities within GPS.
- Innovation: Develop innovative approaches to delivering on core activities that integrate new technologies, including AI.
Job Requirements & Qualifications:
- Education / Licenses: MD / MBBS, PharmD (Doctor of Pharmacy), BDS (Bachelor of Dental Surgery), or MDS (Master of Dental Surgery); or Nurse Practitioner (NP) with strong pharmacovigilance and hands‑on ICSR case processing experience. Active registration with, or eligibility for registration with, the relevant Indian professional regulatory body is required.
- Minimum Experience: 5+ years of pharmacovigilance case processing experience required, with direct hands-on exposure to ICSR intake, Argus Safety, and expedited reporting. High-volume case processing and prior triage or first-line safety review experience strongly preferred.
- Regulatory Knowledge: Strong knowledge of ICH E2A, E2B, E2D guidelines, FDA/EMA and Health Canada pharmacovigilance regulations.
- Technical Skills: Hands-on experience in ICSR intake, case processing, and expedited reporting logic. Proficiency with Argus Safety or equivalent safety database.
- Clinical Judgment: Ability to interpret Reference Safety Information (IB / USPI / SmPC) and apply expectedness determinations. Rapid, well-reasoned clinical judgment under time pressure; high attention to detail.
- Communication: Clear written communication skills; summaries must be accurate, concise, and action able
- Preferred Skills: MedDRA familiarity preferred; experience with AI technologies and exposure to Gen AI tools in a PV setting a plus.
Click on Apply to know more.