Utrecht

Pharmacovigilance and Regulatory Affairs

  • Professional
  • Pharmaceutical
  • Regulatory Affairs & Pharmacovigilance
  • Vast (1,0 fte)
  • The Netherlands
  • Utrecht
  • Pharmaceuticals in Middle Netherlands

In the role of Medical Shared Services Associate, you will be asked to ensure affiliate compliance with internal and external requirements concerning Pharmacovigilance and Regulatory Affairs in the Netherlands, to ensure legal duties are executed and timelines are met. This includes compliance to:

  • Drug Safety legal obligations and procedures, documentation and deadlines;
  • Labeling and information compliance;
  • PSP protocol implementation and compliance;
  • Affiliate Labeling Responsible Person (ALRP) activities: perform all tasks related to packaging development and assist the Senior Regulatory Affairs Associate

Does this description sound like a welcoming option for you? Get in touch with a consultant to hear more about the extent of this role.

Job Responsibilities

  • Responsible for appropriate communications between patient safety local and global and with Product Complaint organization, Medical and Regulatory Affairs;
  • Responsible for ensuring compliance with local regulatory compliance and GPS policies, procedures and processes;
  • Ensure identification, retrieval, acknowledgment and distribution of AE information;
  • Collect and document all AEs with products reported spontaneously for marketed products and those SAEs associated with clinical trials and post-marketing surveillance studies;
  • Review action items and redact follow-up letters to the Health Care Professionals (HCPs) personally or with the Manager - QPV & Medical Shared Service;
  • Responsible for submitting Development Safety Update Reports (DSUR) and Line Listings following national guidance and ensure tracking of these submissions;
  • Submitting expedited reports from LSS for submission to local regulatory agencies regarding the medical devices in order to meet regulatory requirements and ensure tracking of these submissions;
  • Participate in the preparation of all documents for the submission of RMA materials to CBG according to applicable Dutch regulatory requirments and CBG guidelines;
  • Reporting totals, trends, metrics, deviations and compliance of affiliate (S)AE reporting to appropriate functions such as medical lead and E&C manager;
  • Spokesperson for Safety procedures concerning pharmacovigilance activities during inspections and/or audits of the Medical Department or specific trials/departments.

Job Requirements

  • At a minimum a completed Bachelor’s degree and 2 years of relevant experience
  • Living in the Netherlands
  • Fluent Dutch and English language skills – written and verbal
  • Attends national training meetings and symposia as continuing education.
  • Ability to interact with diverse groups and individuals
  • Knowledge of the local (national) requirements/legislation regarding regulatory submissions and approvals
  • Strong administrative skills (e.g. filing and documenting systematics; confidential data handled)
  • Able to work in local and international teams
  • Excellent communication, interpersonal, and negotiation skills
  • Being able to retrieve information in databases

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Joan van Droffelaar

Consultant Medical


M (06) 53 662 681

T (035) 543 00 21

Send e-mail

Juliana Stracquadaini Leon

Consultant


T (035) 543 00 21

Send e-mail

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