Associate Director / Director Safety Scientist

ZipRecruiter; Welwyn Garden City; Hybrid; GBP 70,000 - 90,000; Full time

Job summary

A global biopharmaceutical company is seeking an experienced Associate Director / Director Safety Scientist. This role involves supporting safety oversight in drug development, managing case reporting activities, and contributing to regulatory submissions. Ideal candidates will possess a life sciences degree and significant drug safety experience. Offers a hybrid working model with 8 office days per month.

Qualifications

• Proven experience as a Safety Scientist in drug safety and regulatory filings.
• Understanding of GxP and regulated processes.
• Ability to present scientific data clearly.

Responsibilities

• Support early and late phase development activities in the safety team.
• Manage individual and aggregate case reporting activities.
• Contribute to regulatory authority submissions.

Skills

Drug safety experience

Clinical development

Data analysis

Communication skills

Project management methodology

Education

Primary life sciences degree

Relevant postgraduate degree

Job description

Overview

Your new company: My client is a global biopharmaceutical company focused on healthcare innovation and environmental sustainability, with priorities in Oncology, neurology, rare diseases, ophthalmology and immunology. There is an opportunity for an Associate Director / Director Safety Scientist to join their team. Hybrid work arrangement: Office 8 times in a month.

Your new role

As a highly motivated individual, you will support early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting, this may include signal evaluation, safety-related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management.

• Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas
• Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER)
• Responsible for signal detection and management activities and contributing to the strategy and review of safety assessments and drug safety reports for signals or issues (inc. product quality) or in response to Regulatory Authority requests
• Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS
• Contributing to study management from a safety perspective through SMT/PET and document review and maintenance across the development continuum (early phase to post-marketing studies), including PASS
• Contribute to regulatory authority submissions (INDs, NDAs, MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with the team
• Establish and maintain collaborative working relationships with all key stakeholders, and internal and external customers and ensure the same across relevant teams
• Consistently comply with all governing laws, regulations, SOPs and other guidelines

What you'll need to succeed

• Primary life sciences degree and relevant postgraduate degree
• Proven drug safety, clinical development experience in the pharmaceutical industry, ideally as a Safety Scientist — including signal evaluation, safety-related activities associated with new drug applications/regulatory filings, benefit-risk assessment, safety risk management and aggregate report writing
• Understanding of GxP and regulated processes and end-to-end clinical trial lifecycle
• Strong towards process improvement and cross-functional teamwork
• Excellent communication skills, both written and verbal
• Ability to perform data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
• Good presentation skills, effective at summarising and presenting key considerations and decision points
• Understanding of project management methodology

What you need to do now

Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and residing in the UK.

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on 03330106292