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Job Details

Patient Safety Specialist

Company: CTC Resourcing Solutions
Location: Basel, Switzerland
Reference: 895597-P
Closing Date: 01 Oct 17
Type: Contract
Salary (£): On Application
Benefits: Competitive

Job Summary:

For one of our clients, a multinational pharmaceutical company, we are currently looking for an

Requirements:

Reference Number:         895597-P

Type of placement:         Contract – 9 Months

Location:                        Basel, Switzerland

 

 

Main Responsibilities:

 

  • Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all 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 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 organization.
  • 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
  • Drives the local execution of the RMP for al group products in Switzerland and Liechtenstein:
    • Ensures training on RMP principles and RMP product specifics of Country Organization staff (incl. Sales/Marketing staff) involved in the implementation of the RMP
    • Supports the Country Head Patient Safety in the timely and compliant execution locally of the Pharmacovigilance activities defined in the RMP
    • Liaises with the other departments in the Country Organization such as Clinical Research Operations, Medical, Regulatory Affairs or Sales/Marketing to ensure alignment of all local functions in support of the RMP
    • Liaises with Sales/Marketing to ensure implementation of educational materials

 

  • Liaises with Local RA to ensure tracking of status of the RMP commitments implemented locally
  • Is obligated to report any Adverse Event or Technical Quality Complaint within 24h from the receipt to the Patient Safety Desk or Complaint Coordinator
  • in accordance to the valid local SOPs.

 

 

Qualifications and Experience:

 

  • Education (minimum/desirable): Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist).
  • Fluent in both written and spoken English
  • Fluent in both written and spoken German
  • Knowledge of national and international regulations for pharmacovigilance
  • Knowledge of pharmacological and medical terminology.
  • Excellent communications, interpersonal and negotiation skills
  • Quality and focus oriented
  • Additional educational requirements as may be mandated by national requirements
  • Relevant working/residency permit or Swiss/EU-Citizenship required

Apply for this job: Patient Safety Specialist

Contact Information:

Address:  CTC Resourcing Solutions
Greifengasse 1
CH-4058 Basel
Switzerland
Reasons to work for CTC
Tel:  +41 61 695 88 66
Fax:  +41 61 695 88 67
Website:  Visit Our Web Site

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