Senior Specialist, Pharmacovigilance

What you'll do

• Manage day-to-day pharmacovigilance operations and lead a team to ensure compliance with local regulations and internal standards.
• Provide metrics to monitor the performance and functioning of the pharmacovigilance system.
• Develop, maintain, and assess local procedures in alignment with corporate policies and requirements.
• Process, translate, and conduct follow-ups for adverse events from both spontaneous and solicited sources.
• Prepare and submit periodic safety reports including J-DSUR, J-PSUR, and re-examination dossiers.
• Manage internal audits, third-party audits, and regulatory authority inspections while tracking CAPA actions to completion.
• Ensure training compliance by maintaining the PV Training Matrix and developing necessary training materials.
• Monitor local safety data for EPPV products and communicate potential concerns to affiliate safety science teams.

What we're looking for

• A minimum of 2 years’ experience in pharmacovigilance or a related field is required.
• Must be an effective communicator capable of working in team and cross-functional environments.
• Must demonstrate a strong commitment to compliance with relevant rules and procedures.
• Must possess effective planning and organizational skills to complete activities with high quality.