Responsibilities
- Supports the generation of performance metrics to monitor the effectiveness and compliance of the pharmacovigilance system against local regulations and internal timelines.
- Captures, processes, follows up on, and translates adverse event reports and safety data from both spontaneous and solicited sources.
- Conducts expedited Individual Case Safety Report (ICSR) submissions in accordance with local regulatory requirements.
- Conducts medical and scientific literature reviews in the local language to identify safety signals.
- Implements local quality control processes to maintain accuracy and consistency in safety data entry and reporting decisions.
- Performs adverse event reconciliation and ensures sampling methods for AE detection align with global standards.
- Collaborates with Safety Science and other teams to lead the preparation of periodic safety reports for assigned therapeutic area products, including J-DSUR, J-PSUR, and re-evaluation dossiers.
- Ensures timely submission of periodic safety reports and maintains documentation to support compliance.
- Supports internal pharmacovigilance audits, affiliate service provider audits, and inspections by regulatory authorities.
- Ensures all pharmacovigilance processes are established and maintained for activities involving potential safety data handling, per company and local requirements.
- Develops in-depth understanding of Risk Management Plans (RMPs) to support local implementation of enhanced post-marketing pharmacovigilance (EPPV) activities.
- Coordinates with affiliate safety science teams during the development or update of country-specific RMPs, where applicable.
- Monitors local safety data under EPPV and communicates emerging trends or concerns to safety science for assessment.
- Works with Safety Science and the Safety Control Manager to ensure successful product launches and new indication approvals in Japan through compliant local strategies.
- Reviews protocols for regulatory post-marketing observational studies (Reg-PMOS) from a safety standpoint for assigned therapeutic areas and products.
Work Arrangement
Remote (Country) — Japan
Team
Role involves leading a team of PV operations.
Other
- Must be based in Japan.
- Reports directly to Japan PV Operational Lead.
- Role involves leading a team of PV operations.
