Chiltern is the leading, global mid-sized contract research organization. We listen to client needs to deliver customized clinical development solutions with a team of more than 4,300 working across 47 countries to provide comprehensive, yet flexible and responsive, services. Our specialties include clinical development, Oncology, Devices and Diagnostics, Data, Analytics & Evaluation and Strategic Service Provision.
Chiltern is looking to recruit a Pharmacovigilance Associate office based in Lisbon to be dedicated to one of our sponsors, a global pharmaceutical company.
This position is permanent full time.
DUTIES & RESPONSIBILITIES
- Manage collection, processing, documentation, reporting and follow-up of all adverse event reports from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc.
- 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 operations.
- Survey and monitor national pharmacovigilance regulations and provide update to global organization.
- Develop, update and implement local procedures to ensure compliance with global procedures and national requirements.
- 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 Safety databases.
- Develop and update training materials for pharmacovigilance and ensure training of country colleagues on relevant procedures for AE reporting (including field force and third party contractor, if applicable).
- Ensure support for audits, corrective action plan, and investigation and Health Authority inspections.
- At least 2 – 3 years experience in a similar role are required.
- Excellent verbal and written communication in English.
- Ability to understand various key stakeholders and customers to respond appropriately.
- Ability to work effectively in a team environment.
- Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives.