Patient Safety Specialist
Il y a 2 mois
**Patient Safety Specialist**:
- Location:
Vilvoorde
- Contact:
Aurelie Petit
- Job type:
Contract
- Contact phone:
+32 10685332
- Industry:
Pharmaceutical
**Introduction Sentence** Our pharma client is looking for a Patient Safety Specialist to reinforce the team. Do you have a scientific background and a special interest in patient's safety ? Then this may be for you
To support management of Patient Safety operational processes at Country Organization ensuring compliance with Client global and local procedures, national and international regulations/ standards/ guidelines for vigilance of both marketed and investigational products (incl. drugs, food supplements and medical devices) from Client.
**Responsibilities**
- Manage the collection, processing, documentation, reporting and follow-up of all adverse event reports for all Client products from Clinical Trials, Non-interventional Studies, Patient Oriented Program (POPs), Literature, Spontaneous Reports, and any other source of information. Transcribe, translate, and enter data from source documents into safety systems accurately and consistently with focus quality and on timeliness. When case processing activities are externalized, liaise with the respective External Service Providers to ensure Client Procedure's compliance.
- Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
- Interact and collaborate with other departments (such as Medical Affairs, Marketing, Patient Engagement, etc.) to ensure that any projects/ initiatives that potentially involve safety data collection (POPs, DEAs, SM/SML, etc.) follow the Client vigilance requirements.
- Perform reconciliation with other departments (e.g., Medical Information, Quality Assurance, and Third-party contractors, as applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
- Management and maintenance of all relevant local Patient Safety databases
- Ensure that relevant local literature articles are screened as appropriate.
- 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 vigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third-party contractors, as applicable
- Ensure support to the internal audits, LHA inspections and implementation of the respective CAPA plan
**Requirements**:
- Education: Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience.
- Experience in Patient Safety is a plus
- Languages: Preferably fluent in both written and spoken English, Dutch and/or French.
- Experience/Professional Requirement:
- Knowledge of national and international regulations for pharmacovigilance
- Knowledge of pharmacological and medical terminology
- Good communication and interpersonal skills
- Quality and results oriented
- Computer skills
- Existing right to work in Europe required
**Benefits**
- Open to freelancer and employee profiles
- Part time : 50% as of September 2023 100%
- A balanced salary package based on your skills and experience
- Work - Life balance : 1 days/week on site
Vacancy number: 21576
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