Senior Patient Safety Specialist, Netherlands - L

30 Apr 2021
30 May 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
TalentSource Life Sciences is currently searching for an experienced Senior Patient Safety Specialist to join one of our partner companies, a large pharmaceutical company involved in a wide range of therapeutic areas.

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
  • 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
  • Develop and update training materials for pharmacovigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting.
  • 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

Education and Experience:
  • Health Care Sciences Professional (e.g. Medical Doctor, Nurse,Pharmacist)
  • Knowledge of national and international regulations for pharmacovigilance
  • Knowledge of pharmacological and medical terminology

Experience and Skills:
  • Quality and focus oriented
  • Fluent in both written and spoken English
  • Fluent in both written and spoken Dutch language
  • Excellent communications, interpersonal and negotiation skills
  • Computer skills
  • Additional educational requirements as may be mandated by national requirements

The Benefits of Working for TalentSource in The Netherlands
  • Competitive Salary
  • Group health insurance
  • Great pension scheme
  • 30 Holidays per annum
  • Internet reimbursement
  • Company Car with fuel card depending on the function
  • Dedicated Line Manager
  • Monthly meetings with line manager
  • Full performance and development process with end of year reviews
  • Team events and end of year party
  • Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
  • Employee satisfaction survey - your feedback is important for continuous improvement

Who will you be working for?


CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @

or please contact for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Key words: Patient Safety Senior Specialist, Patient Safety
Skills: Drug Safety Location: Netherlands Share:

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