Associate Director, Safety - St Albans, United Kingdom - Achieva Group

Description

• St Albans, Hertfordshire, South East, England
• Posted 3 hours ago

• 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
• 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

• Demonstrates independence and high competence in the conduct of all safety science responsibilities
• Actively emulate and role model the Roche values, culture (mindset and behavior), Roche core competencies and PD/PDS strategy and drive for similar performance across relevant team
• Demonstrates behaviors consistent with Roche 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 Roche 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 mínimal 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 crossfunctional 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.

• Qualified healthcare professional or Life Sciences graduate.

• Relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; PharmD or other postgraduate 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 crossfunctional teamwork
• Effectively work with remote partners on a global team
• Excellent communication skills, both written and verbal
• Strong presentation skills, effective at summarizing and presenting the key con