Senior Safety Scientist

Portfolio Clinical Safety Scientists provide 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 Leaders) depending on the deliverable/activity. 

The Scientists 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 signal management activities, safety activities associated with new drug applications/regulatory filings, benefit-risk assessments and overall 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. 

Job Responsibilities: 

Under the matrix leadership of the SSL and/or in collaboration with PCS colleagues, the Senior Safety Scientists are responsible for:

• Developing and maintaining an understanding of the safety profile of their assigned product(s) or therapy areas 

• Aggregate case reporting activities (e.g. DSUR, PBRER) 

• Signal management activities including, but not limited to signal detection and supporting signal assessment deliverables

• 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

• Supporting Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable 

• Coordination and collaboration with vendors servicing Safety Science 

Behaviors and responsibilities 

• Demonstrates independence and high competence in the conduct of all safety science responsibilities 

• Ensures all actions are conducted in alignment with Roche quality management systems 

• Develops and maintains 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 

• Establishes and maintains collaborative working relationships with all key stakeholders, and internal and external customers and ensure the same across relevant teams 

• Consistently complies with all governing laws, regulations, Roche standard operating procedures (SOPs) and other guidelines 

Who You Are:
(Required)

• You are a qualified healthcare professional and/or Life Sciences graduate

• You have 2+ years of R&D (drug safety, clinical development or medical affairs) experience in the pharmaceutical / life sciences / healthcare industry

• You have a strong understanding of GxP and regulated processes; the full end to end clinical trial lifecycle

• You have demonstrated experience working in a cross functional team

• You have experience working on a global team; ability to support process improvements, perform data analysis / statistical methods to evaluate, interpret and present scientific data with clarity 

• You have strong presentation skills, are effective at summarizing and presenting the key considerations and decision points; you understand project management methodology 

Preferred:

• You have an advanced degree (e.g. PHD/MSc/RN/PharmD) in a Life sciences discipline

• You have strong interpersonal skills: Outstanding interpersonal, verbal, and written communication and influencing skills: has built and cultivated important relationships both inside an  organization and externally. Has proven abilities to influence internal partners and stakeholders, thought leaders, national advocacy  organizations,