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Over deze vacature

Patient Safety Senior specialist


Functie omschrijving

- Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all
the clients 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 operations in cooperation
with other Country Organization Departments.

- Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.
- Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional
groups and third party contractor, if applicable.

- Survey and monitor national pharmacovigilance regulations and provide update to global Patient Safety

- Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.

- Input, review and approval of program proposals for language, content and establishment of necessary
controls on collection and reporting of adverse event information.

- 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 LHA, 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, investigation and Health Authority inspections.

- Ensure training and oversight of staff, as applicable.

- Manage and maintain efficient Patient Safety filing and archive system.

- Review of all Phase IV Clinical Trial and NIS protocols safety sections and if a Contract Research Organization (CRO) is conducting the trial, review the contract (SSW), train the CRO associates responsible from the
trial .

Functie eisen

Education (minimum/desirable):
Health Care Sciences Professional (e.g. Medical Doctor, Nurse,

- Fluent in both written and spoken English
- Fluent in both written and spoken local language

Experience/Professional requirement:
- Knowledge of national and international regulations for pharmacovigilance
- Knowledge of pharmacological and medical terminology.

Excellent communications, interpersonal and negotiation skills:
- Quality and focus oriented
- Computer skills
- Additional educational requirements as may be mandated by
national requirements

Patient Safety Senior specialist

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