++ OUTSIDE IR35 ++
Within this role 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 and may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management.
Job Responsibilities:
- 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 including, but not limited to STAR maintenance, ISMP maintenance. Contribute 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
- Contribute to the development of the product safety strategy and provide drug safety input into the Clinical Development strategy
- Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance (including the IB), risk communications, RMP, REMS
- Contributing to study management from a safety perspective through SMT/PET activities and document review and maintenance across the development continuum (early phase to post marketing studies), including PASS
- Contribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with SPL
Responsibilities:
- Demonstrates independence and high competence in the conduct of all safety science responsibilities
- Demonstrates behaviors consistent with the clients values and engenders confidence from senior management
- Develop and maintain knowledge of the pharmaceutical industry and drug development, including a comprehensive knowledge of pharmacovigilance activities and requirements
- Ensure all actions are conducted in alignment with the clients quality management systems
- Under certain conditions, may take on the role of ?Safety Strategy Lead (SSL)? for one or more assigned molecules. The SSL is the lead safety accountable for the molecule safety strategy.
Education:
- Minimum Qualifications: Qualified healthcare professional or Life Sciences graduate. Preferred Qualifications: A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; PharmD or other post-graduate health professional qualifications) would be advantageous.
- Principal Scientist (lvl 3): 4 or more years of drug development experience in the pharmaceutical or related industry including at least 2 years in drug safety or a closely related field.
- Understanding of GxP and regulated processes and end to end clinical trial lifecycle
- Strong orientation towards process improvement and cross-functional teamwork
- Effectively work with remote partners on a global team
- Excellent communication skills, both written and verbal
- 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
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@achieva.co.uk
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- Agency: Achieva Group Limited
- Reference: BH-34447
Website: Achieva Group Limited
- Posted: 8th March 2023
- Expires: 5th April 2023
