Regulatory Compliance Associate

3 dni temu


Warszawa, Mazovia, Polska Prime Vigilance Ltd Pełny etat
Job Details

We are seeking a highly motivated and experienced Regulatory Compliance Associate to join our team at Prime Vigilance Ltd.

The successful candidate will be responsible for managing case processing services with full accountability, working independently as part of a project team to perform and support contracted pharmacovigilance activities on behalf of our company.

Responsibilities

The successful candidate will be responsible for:

  • Processing Individual Case Safety Reports from all sources in compliance with applicable regulations and client-specific requirements.
  • Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations)
  • Preparation of database outputs for periodic reporting
  • Mentoring and training of new employees within the department
Qualifications

To be successful in this role, you will need:

  • A Life science / bio medical background – healthcare-related degree qualification
  • Demonstrated experience in Pharmacovigilance case processing
  • Time and issue management, delegation, organization, and multitasking skills
  • Strong interpersonal and communication skills
  • Advanced English skills, both verbal and written, at least C1
About Us

At Prime Vigilance Ltd, we prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders, and ages can contribute and grow.

We offer:

  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly, supportive working environment
  • Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you, then Prime Vigilance could be a great company to consider.

  • Quality
  • Integrity & Trust
  • Drive & Passion
  • Agility & Responsiveness
  • Belonging


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