Position Overview
* Job Function: Product Safety
* Job Sub‑Function: Drug & Product Safety Operations
* Job Category: Professional
* Hybrid work model
Locations
* Bangalore, Karnataka, India
* Hyderabad, Andhra Pradesh, India
* High Wycombe, Buckinghamshire, United Kingdom (later to move to Maidenhead in 2026)
* Raritan, New Jersey, United States of America
* Titusville, New Jersey, United States of America
* Horsham, Pennsylvania, United States of America
Responsibilities
* Set up and maintain Distribution Anchors (DAs) in the Global Safety System.
* Collaborate with internal and external partners to ensure DAs comply with regulatory reporting requirements.
* Write and update procedural documents and support continuous process improvement.
* Train and mentor other staff in DCM processes.
* Manage daily workload, ensuring Distribution rule‑related tasks are completed on time.
* Perform quality control activities on individual and team work.
* Conduct informal testing of new or modified DAs when required.
* Maintain close liaison with the Distribution Configuration Management team for workload management.
* Deputize for the Manager/Director as identified.
* Contribute to team meetings, identifying and resolving processing issues.
* Drive the creation and continuous improvement of consistent processes that meet internal and regulatory standards.
* Develop metrics to monitor key performance indicators across DCM areas.
* Assist the Manager with process implementation and issue management.
* Identify and resolve issues, preparing documentation and escalation options when necessary.
* Conduct impact assessments and bolus management activities related to DAs.
* Provide support and training to ensure compliance with collaboration with business partners and regulatory authorities.
* Assist with service level agreements (SLAs) between GMSO and Marketing Authorization Holders (MAHs) or Pharmacovigilance Agreements (PVAs).
* Liaise with other functional areas to resolve queries and issues.
* Act as a subject‑matter expert for regulatory reporting intelligence, quality monitoring activities, process/system improvement, compliance and quality metrics, controlled document creation/update and CAPA activities.
* Assist in maintaining knowledge of worldwide regulations related to ICSR case processing and reporting.
Minimum Qualifications
* Degree and/or relevant work experience (advanced degree preferred).
* Understanding of US and EU electronic regulatory reporting requirements for ICSR.
* Experience in pharmacovigilance operations, including single case processing, database queries, and expedited reporting.
* Knowledge of regional and global safety regulations.
* Familiarity with technologies, systems and databases related to E2B electronic reporting.
* High reliability and compliance with legal and company guidelines.
* Excellent organizational and communication skills, including presentation abilities.
* Ability to produce high‑quality work under time‑critical and high‑pressure situations.
* Project management skills desirable.
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