Snr Clinical Safety Specialist

The Senior Clinical Safety Specialist will serve as a cornerstone in the operational framework of our Global Drug Safety department. In this pivotal role, you will spearhead technical activities, offer indispensable support for project delivery, and mitigate risks identified by project managers. Additionally, you will collaborate cross-functionally, extending your expertise to support technical activities across various units within the Global Drug Safety department.


What will be your key responsibilities:


Role Description

As our Senior Clinical Safety Specialist, your core responsibilities will include:

  • Executing tasks pivotal to assigned projects, ensuring operational excellence and adherence to stringent PV processes.
  • Providing guidance and support to line reports and peers, ensuring seamless application of PV processes as required.
  • Overseeing all facets of safety report processing—from receipt and coding to submission—across diverse sources.
  • Facilitating reconciliation of safety reports with clinical databases and conducting periodic screening of local country reporting requirements.
  • Conducting or supporting crucial activities such as global literature monitoring, medicinal product management, and signal management.
  • Assisting in the development and revision of safety management plans and clinical safety documentation.
  • Managing project-related contracts and contributing to regulatory intelligence activities.
  • Delivering comprehensive training on PV processes to project teams and internal departments.
  • Championing process improvement initiatives and updating procedural documents to reflect evolving best practices.
  • Serving as the primary escalation point for technical project issues and fostering effective communication with internal and external vendors.
  • Providing unwavering support to team members in running projects or processes, ensuring strict adherence to company processes and systems.

Key Responsibilities:

  • Executing assigned projects and tasks with unparalleled precision, ensuring adherence to deadlines and client specifications.
  • Delivering projects and tasks in alignment with personal and departmental KPIs, consistently exceeding expectations.
  • Cultivating robust working relationships with stakeholders and ensuring full compliance with processes and project deliverables.
  • Participating in client meetings and engaging in promotional activities to bolster company presence as needed.
  • Methodically organizing and filing documents in accordance with company document management protocols.
  • Leveraging company databases, systems, and IT tools with utmost proficiency in alignment with company standards.


What experience should you have:

  • Bachelor’s degree or higher in pharmaceutical sciences or related fields (e.g., medicine, pharmacy, life sciences). Advanced degree preferred or equivalent relevant experience.
  • A minimum of 4 years of hands-on experience in a medical or safety department with a robust grasp of medical terminology.
  • Exceptional understanding of drug safety processes and comprehensive knowledge of directives, regulations, and guidelines (e.g., ICH, GVP, GCP, CIOMS).
  • Extensive experience navigating safety databases with finesse and proficiency.
  • Proficiency in verbal and written English, coupled with outstanding interpersonal skills.
  • A collaborative team player with exemplary organizational and time-management abilities.
  • Superlative communication skills and a demonstrated ability to foster a positive, results-oriented work environment.

What do you get in return:

  • Friendly work environment
  • Multinational team with 30 nationalities
  • Flexible working hours, working from home
  • Remote work is possible
  • 25 days holidays plus 3 personal days
  • Home Office Stipend
  • Dog Friendly offices


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