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Director Safety Scientist

CK Group

Welwyn

Hybrid

GBP 70,000 - 100,000

Full time

6 days ago
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Job summary

A leading global pharmaceutical company is looking for a Director Safety Scientist in Welwyn. This permanent position requires expertise in safety science and pharmacovigilance, overseeing safety documents and ensuring compliance with regulatory standards. The ideal candidate will possess strong experience in clinical development and a relevant degree.

Qualifications

  • Experience in pharmacovigilance, clinical development, or medical affairs.
  • Strong understanding of global regulatory requirements and safety reporting.
  • Significant experience in regulatory safety submissions.

Responsibilities

  • Provide safety science and pharmacovigilance support across the drug development lifecycle.
  • Review and assess individual and aggregate case safety reports.
  • Ensure compliance with quality systems and global regulations.

Skills

Safety science
Pharmacovigilance
Regulatory compliance
Signal detection
Understanding of GxP standards

Education

Degree in healthcare or life sciences
Postgraduate qualification (e.g. MSc, PharmD, MD, PhD)

Tools

Signal management systems
Drug safety databases

Job description

Job Title: Director Safety Scientist

Location: Welwyn, with Hybrid work

Salary: £competitive market salary

Type: Permanent


CK Group are recruiting for a Director Safety Scientist, to join a growing global pharmaceutical company, on a permanent basis, in Welwyn, Hertfordshire, UK.


Director Safety Scientist will require you to:
  • Provide safety science and pharmacovigilance support across the drug development lifecycle, from early-phase trials to post-marketing.
  • Develop and maintain a deep understanding of the safety profile of assigned products or therapy areas.
  • Lead and contribute to signal detection and management activities.
  • Oversee safety-related documents including CCDS, RMPs, REMS, DSURs, and PBRERs.
  • Act as a key safety contributor on study teams and within global regulatory submissions (INDs, NDAs, MAAs, variations, renewals).

Further Responsibilities will include:
  • Reviewing and medically assessing individual and aggregate case safety reports.
  • Supporting labelling document updates and risk communication strategies.
  • Participating in study teams and cross-functional safety discussions, including input on study protocols and post-authorization safety studies (PASS).
  • Ensuring compliance with quality systems and applicable global regulations.

Your Background:
  • A degree in a healthcare or life sciences discipline is required; a postgraduate qualification (e.g. MSc, PharmD, MD, PhD) is preferred.
  • Significant experience in pharmacovigilance, clinical development, or medical affairs within the pharmaceutical industry.
  • Strong understanding of GxP standards, global regulatory requirements, and safety reporting frameworks.
  • Experience with signal management systems, regulatory safety submissions, and drug safety databases.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 140 666 in all correspondence.

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