Safety Scientist

Job content

• Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context
• Responsible for signal detection and management activities. Contribute to the review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests
• Provide expert contribution to the development of the product safety strategy
• Take independent responsibility for risk management activities including preparation and maintenance of CCDS, labelling document maintenance (including IB), risk communications, RMP, REMS
• Review of clinical protocols, study reports, Investigator’s Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication
• Take responsibility for safety science contributions to regulatory authority submissions
• Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB
• Perform specialised roles with PCS. These may include, but are not limited to; functional business process owner, subject matter expert, safety committee member.
• Responsible for coordination and collaboration with vendors servicing Safety Science

• Education in Life Sciences
• Preferred Qualifications: A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; PharmD or other post-graduate health professional qualifications
• 6+ years of drug development experience in the pharmaceutical or related industry including at least 3 years in drug safety
• Hands on experience with clinical trial and mature products safety
• Hands on working experience with Risk Management Plan, Protocols, DSR, DSUR, CSR, IB, Adverse Events, etc.
• The ability to demonstrate a broad understanding of the scientific aspects of safety, PV and clinical/patient risk management (e.g., via demonstrable knowledge of the application of GVP, GCP & CTR requirements) is essential.
• Demonstrated ability to lead and influence, with and without authority, in a global matrix environment.
• Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.
• Evidence of proactive, structured thinking with the ability to rapidly respond to an evolving and complex environment.
• Apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
• Strong presentation skills, effective at summarizing and presenting the key considerations and decision points
• Ability to effectively train others on departmental practices and processes