Senior Safety Scientist​/Associate Director​/Director

Position: Senior Safety Scientist / Associate Director / Director
Location: Welwyn

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.

Join Roche, where every voice matters.### ### The Position Join Roche as a
** Senior Safety Scientist / Associate Director / Director** ! We're looking for talented professionals at various experience levels. The position provides hands-on safety science and pharmacovigilance support to molecules across the Roche portfolio. As an individual, they are responsible for all aspects of safety science/pharmacovigilance, with accountability being held by Portfolio Clinical Safety (PCS) leadership and experts or SSLs (Safety Strategy Program Leaders) depending on the deliverable/activity.

The Portfolio Clinical Safety Scientists (PCS-Sci) supports early and late phase molecule 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.
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* 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. 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  Company Core Data Sheet (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 behaviors 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
** Who you are:
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* 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; Pharm

D or other post-graduate health professional qualifications) would be advantageous
* Safety scientist (level
2): proven drug safety, clinical development or…