Job Description

• Support management of Patient Safety operational processes at ensuring compliance with global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of marketed and investigational products (drugs and devices).

• Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.

• Manage reporting/submission/distribution of safety reports/updates/information (e.g.SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities and/or clinical

• Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.

• Interact and exchange relevant safety information with Patient Safety associates, other functional groups and third party contractor, if applicable.

• Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.

• Management and maintenance of all relevant Patient Safety databases.

• Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to local health authority, development and implementation of corrective action(s) as needed.

• Develop and update training materials for pharmacovigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third party contractor, if applicable.

• Ensure support for and close-out of audits, corrective action plan, and investigation and Health Authority inspections.