MedDRA Specialist | Senior Process Compliance Review & Analysis

Pune, IndiaRemote

Responsibilities

Compile metrics and identify quality trends.
Prepare initial drafts of Corrective and preventive actions.
Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC’s, Med Guides etc.
Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines.
Draft sections of the Quality Management Plan for assigned project.
Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager.
Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to
Guide safety associates in managing voice calls (as required).
Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources.
Perform Analysis of data and if required, suggest strategies for process improvement/excellence.
Perform and Review of analysis of data performed and drive strategies for process improvement/excellence.
Take ownership of assigned aspects of quality reviews on projects.

MedDRA certified will be preferred for this position Summary of
Qualifications (Minimum Required): Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, or related area.
Fortrea may consider relevant and equivalent
experience in lieu of educational requirements.
experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with at least One year of
experience in Peer review/Quality review. Knowledge of regulatory requirements viz.