My client is a Global Pharmaceutical Development company urgently recruiting for an Associate Safety Director.
Job Purpose: Portfolio Safety Scientists provide safety science and pharmacovigilance support to molecules across the portfolio. As a group, they are responsible for all aspects of safety science/pharmacovigilance, with accountability being held by PCS leadership and experts or SSLs (Safety Strategy Program Leaders) depending on the deliverable/activity.
Under the matrix leadership of the SSL and in collaboration with PCS colleagues
- Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas. Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action)
- 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, labelling 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.
Education, Skills and Experience
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