Senior Safety Officer

1 month, 4 weeks ago
Full-time
Mid Level
Technical Writing and Documentation
Excelya

Excelya

Excelya is a global CRO offering full-service, FSP, and Resourcing solutions to Biotech, Pharma, and Medical Device companies, prioritizing people-first healthcare advancements.

Professional Services
251-1K
Founded 2014

Description

  • Compile, author, and review aggregate periodic safety reports (PSURs/PBRERs, DSURs, ACOs) to regulatory standards.
  • Lead coordination and development of clinical safety evaluations, cumulative safety analyses, and benefit–risk assessments.
  • Ensure safety reports and narratives are clear, accurate, and compliant with global regulatory requirements.
  • Collaborate with cross-functional teams to gather clinical and safety data needed for aggregate reporting.
  • Provide medical writing for aggregate reporting activities and related documentation.
  • Support pharmacovigilance activities such as risk management plans, regulatory submissions, and compliance oversight.
  • Contribute to SOP development, training, audit activities, and implementation of CAPAs when required.
  • Maintain timelines and quality standards for safety report deliverables and coordinate review processes.

Requirements

  • Degree in Life Sciences (Pharmacy, Medicine, Biology, Chemistry); advanced degree (MSc, PhD) is a plus.
  • Minimum 3 years of experience in pharmacovigilance, including at least 2 years hands-on experience writing aggregate safety reports (DSURs, PSURs/PBRERs).
  • Fluent in English; proficiency in French is preferred.
  • Strong medical writing expertise, including clinical safety evaluations, benefit–risk assessments, and cumulative safety analyses.
  • Ability to translate complex clinical and safety data into clear, regulatory-compliant narratives.
  • Solid knowledge of ICH E2C(R2), E2F, and GVP guidelines.
  • Strong analytical skills and high attention to detail.

Benefits

  • Opportunity to work in a growing mid-size CRO (≈900 employees) with a focus on becoming a European leader.
  • Exposure to diverse projects across full-service, functional service provider (FSP), and consulting models.
  • Work alongside preeminent experts, supporting professional growth and scientific development.
  • An environment that values individual talents, encourages audacity, and supports career evolution.
  • A collaborative, inclusive culture that emphasizes teamwork and improving the patient journey.

Interested in this position?

Apply directly on the company website

Apply Now

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