Safety Expert

8 hours ago


Stockholm, Stockholm, Sweden TFS HealthScience Full time

We are a mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies worldwide. Our services include full-service capabilities, resourcing, and functional service solutions.

The QPPV/Safety Manager is part of the Project Delivery organization and is responsible for managing Drug Safety in accordance with company policies, SOPs, and regulatory requirements.

Key Responsibilities:

  • Holding QPPV responsibilities for some clients.
  • Managing Post marketing Safety-only projects.
  • Preparing safety sections in various regulatory documents.
  • Conducting literature reviews.
  • Collecting, assessing, and entering spontaneous adverse event reports into the safety database in line with client SOPs and regulatory requirements.
  • Reviewing and approving processed cases and AE/SAE reconciliations.
  • Coding adverse events, medical history, and concomitant medication using MedDRA and WHO-Drug Dictionary.
  • Quality checking and approving coded data.
  • Electronic submission of reports to EudraVigilance.
  • Contributing to post-approval surveillance plans and SOPs.
  • Updating safety handling templates in line with relevant SOPs.
  • Participating in relevant meetings and sharing information with relevant teams.
  • Providing internal support to other departments.
  • Collaborating on improvement projects with other departments.
  • Contribution to organizational development and routine enhancements.
  • Validation of computer applications specific to the department regarding drug safety requirements.
  • Staying up-to-date on pharmacovigilance laws, directives, and guidelines.
  • Mentoring and supervising new Drug Safety staff.
  • Participating in marketing initiatives.

Requirements:

  • Bachelor's degree in a life science or nursing field; or equivalent.
  • Proven experience working as a QPPV or Deputy QPPV.
  • Ability to thrive in a fast-paced environment with changing priorities.
  • Familiarity with medical terminology and science related to assigned medications and therapeutic areas.
  • Understanding of Pharmacovigilance legislation.
  • Able to work independently and as part of a team with minimal supervision.
  • Excellent written and verbal communication skills.


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