How you’ll spend your day
Processing serious & non-serious adverse events from various post-marketing sources.
Ensure accurate and consistent medical coding through MedDRA (Medical Dictionary for Regulatory Activities) for all events in Safety Database.
Data verification between source documents and entered data in Safety Database for evaluation of events/suspect drug coding, seriousness, causality, listedness and narrative writing.
Evaluate the need for follow-ups, queries with various stakeholders for correct and accurate data transfer to various parties.
Ensure that quality data is analyzed for any trending and to prepare team for process stabilization.
Providing administrative support by taking up complete responsibility of assigned case processing related activities on day-to-day basis.
Coordinate with internal/ external stakeholders to obtain necessary information required for day-to day operations and to update the reporting manager on status reports on real time basis.
Effective communications to be maintained with internal (related departments and units) & external (partners, authorities, vendors) stake holders in order to run the process as transparent as possible.
to be contd.
Assist in Safety Database related administrative and procedural activities as required or requested and to ensure that all assigned tasks are performed in compliance in accordance to the work instructions and GVP modules.
Ensure that quality of case processing and assigned tasks are evaluated and trends are identified for process improvement.
Various compliance metrics like case timelines, assigned trainings, and TAT for assigned activities are met.
Provide the analytical support to the peers and managers for investigations & analysis of various trends as a part of audits, and inspections.
Mentoring/Training the new hires with case processing knowledge transfer, evaluating their progress close to perfection during their initial phases of learning curves.
Your experience and qualifications
M.Pharm/ Pharm.D/ BDS Postgraduate in registered life Sciences
Min 2 – 4 years relevant experience into Pharmacovigilance case processing and related activities in alignment with patient safety operations
