The opportunity
As Lead PV Professional, Medical Reviewer/Clinical Assessor within the ICSR operations sub-function within Patient Safety Operations (PSO), the role in the Global Patient Safety & Pharmacovigilance department within Teva Global R&D (Research & Development) reports to the Head of ICSR Operations;
The Lead PV Professional, is responsible for all individual case medical review and inputs for reports originating from spontaneous and organized data collection.
As Medical Reviewer/Clinical Assessor, support the case processors in medical judgement and MedDRA coding of adverse events. Responsible to assess company causality for all types of SAEs and contribute towards coaching and mentoring case processors towards clinical analysis for cases originating from organized data collection
How you’ll spend your day
Perform medical review and clarification of Trial related (AE's) & Post marketing Adverse Evets (ADR's) including narrative content, queries, coding for events and lab reports, expectedness, seriousness, causality, labelling and medical assessment comments as applicable.
Serve as a global safety physician and as an internal (within Teva) & external (to vendors) consultant to pharmacovigilance case processing groups. To have active interactions and provide inputs with other functions for topics related to labelling, causality, seriousness, MedDRA coding and other medical concepts etc.
Maintain awareness of medical-safety-regulatory industry developments to participate in trainings, workshops, product transitions, audit preparations, supporting UAT activities and knowledge transfer transition initiatives.
Support audits and inspections for case processing & medical review aspects
Create and update Standard Operating Procedures and Working Instructions to ensure optimal operational management of ICSR and related activities
Maintain regular communication with the external vendor regarding medical review workflow, process updates and maintain a necessary oversight to address any gaps/risks.
Perform routine quality check to measure the medical review quality for vendor and in-house team
Attend and conduct internal meetings with various stake holders and vendors on various queries/ clarification related to medical assessment concepts for better awareness amongst case processing groups.
Provide support to EU Qualified Persons for Pharmacovigilance (QPPV) teams as applicable. Signal detections following preparation of Risk Management Programs, PSUR/DSUR surveillance activities, participate in Business Continuity Plans (BCP) as required.
Manage paid time off, appropriate backups for the team to ensure smooth operations with minimal disruption.
