Do you have experience within safety / pharmacovigilance ? Furthermore, you have good language skills in ENG/NL/FR, you have good communication skills and an eye for details? Looking forward to an opportunity in the field of patient safety? Then this temporary mission at our client may be a great opportunity for you.
The Patient Safety Specialist takes care of the Patient Safety operational processes at Country Organization and ensures compliance with Client global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance, for both marketed and investigational products (drugs and devices).
- Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Client products.
- Keep safety systems up-to-date accurately and consistently as per the defined timelines.
- Manage reporting/submission/distribution of all safety information to Local Health Authorities and/or clinical operations in cooperation with other Departments.
- Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.
- Keep track of national pharmacovigilance regulations and provide updates to global Patient Safety organization.
- Ensure local procedures are and remain compliant 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.
- Ensure that relevant local literature articles are screened as appropriate.
- Prepare and submit KPI reports on compliance in a timely manner
- Develop and update training materials for pharmacovigilance
- Provide support for 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 for the trial.
- Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent by education, training and experience
- Fluent in both written and spoken English, Dutch and/or French
- Knowledge of national and international regulations for pharmacovigilance
- Knowledge of pharmacological and medical terminology.
- Excellent communication, interpersonal and negotiation skills
- Quality and focus oriented
- Computer skills
- A balanced salary package based on your capabilities and experience, including extra legal benefits.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 17907