The Portfolio Safety Scientists provide safety science and pharmacovigilance support to molecules across my clients portfolio. As a group, they are responsible for all aspects of safety science/pharmacovigilance. 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.
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, 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
Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB
Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable
In partnership with the SSL, support presentation of important safety issues to the Drug Safety Committee (DSC), Development Review Committee (DRC) and other internal and external review and governance committees as needed.
Author or contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals
Acts independently to manage safety responsibilities on study teams and in activities supporting safety science
Behaviours And Responsibilities
Take on the responsibility for specialised roles with PCS. These may include, but are not limited to; functional business process owner, subject matter expert.
Demonstrates independence and high competence in the conduct of all safety science responsibilities
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 quality management systems
Understands how safety activities contribute to company development and commercialisation goals and takes measures to maximize safety value to the organization
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, standard operating procedures (SOPs) and other guidelines
Responsible for coordination and collaboration with vendors servicing Safety Science
Acts independently and with minimal supervision to manage safety responsibilities on study teams and in activities supporting safety science
Trains and mentors more junior PCS scientists
Proactively takes on responsibility for more complex deliverables
Takes on team leadership responsibility in order to manage and complete medium and high priority projects
Seen by peers and cross-functional colleagues as expert in some safety science activities
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.
Willing to challenge embedded behaviors/mindsets, in order to bring new and agile approaches to ways of working, and/or to improve quality and efficiency.
Holds themselves and peers accountable for their behaviours and actions.
Education, Skills and Experience:
- Qualified healthcare professional or Life Sciences graduate.
- Relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; PharmD or other post-graduate health professional qualifications) would be advantageous.
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
Application of project management methodology
- Agency: Achieva Group Limited
- Reference: LC-8
Website: Achieva Group Limited
- Posted: 13th May 2022
- Expires: 10th June 2022