Associate Director / Director Safety Scientist

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The position provides safety science and pharmacovigilance support to molecules across the Roche 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. The Portfolio Safety Scientists (PCS-Sci) supports 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 signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management.

A Senior Safety Scientist will be supported by supervision from one or more experienced colleagues but is expected to be able to work unsupervised on less complex deliverables. They will be expected to continue learning about Safety Science/Pharmacovigilance and the broader aspects of drug development.

Key Responsibilities:

• Under the matrix leadership of the SSL and/or in collaboration with PCS colleagues 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.
• Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS.
• Contributing to study management from a safety perspective through SMT/PET and document review and maintenance across the development continuum (early phase to post marketing studies), including PASS.
• Acts independently to manage safety responsibilities on study teams and in activities supporting safety science.
• 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 SSL and PCS Team Lead.
• Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable.
• Responsible for coordination and collaboration with vendors servicing Safety Science.
• Take on the responsibility for appropriate specialised roles with PCS. These may include, but are not limited to; functional business process owner, subject matter expert.
• Demonstrates behaviours consistent with Roche values and engenders confidence from senior management.
• Understands how safety activities contribute to company development and commercialisation goals and takes measures to maximize safety value to the organization.
• Ensures all actions are conducted in alignment with Roche quality management systems.
• Develop and maintain knowledge of the pharmaceutical industry and drug development, including a comprehensive knowledge of pharmacovigilance activities and requirements.
• Trains and mentors more junior members of the safety team.
• Takes on leadership responsibility in order to manage and complete low to medium priority projects.
• 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, Roche standard operating procedures (SOPs) and other guidelines.

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; Medical qualification; PharmD or other post-graduate health professional qualifications) would be advantageous. Safety scientist (level 2): proven drug safety, clinical development or medical affairs experience in the pharmaceutical or related industry. 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. Perform data analysis/statistical methods to evaluate, interpret and present scientific data with clarity. Good presentation skills, effective at summarizing and presenting the key considerations and decision points. Ability to train others on departmental practices and processes. Understanding of project management methodology.

At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.