Who we are
We are an innovative, curious and diverse company with 80,000 professionals in 150 countries. As a global leader in research-
focused healthcare, we’re constantly learning and growing and seeking people who share the same ambitious vision.
We support our staff in the development of their knowledge and skills. Further local and global career opportunities are offered to people who demonstrate talent and aptitude.
The Safety Science Director will work under the supervision of a Safety Science Group Director, be responsible for particular aspect(s) of an overall program or a group of products and works independently.
Applicable tasks are not limited to those described, may vary by product(s) assigned and may include signal evaluation, safety related activities associated with new drug applications / regulatory filings, benefit-
risk assessment and safety risk management. In most cases, the Safety Science Director will have primary accountability for a program(s) and may also have the role of Safety Science Leader (SSL) for a product / program.
The Safety Science Leader (SSL) is the safety science representative on the Global Development Team (GDT), Lifecycle Team (LCT), Clinical Science Team (CST), Established Products Team (EPT) and / or other related project teams and leads the cross-
functional Safety Team. As such, the SSL is accountable for Safety deliverables for the product or program including the development and execution of the long-
range safety strategic plans for the molecule, including the design, monitoring, analysis, and reporting of studies and other data sources throughout the product life cycle.
The SSL brings safety expertise to interactions with Health Authorities and Data Monitoring Committees and must have the ability to interact effectively in a multifunctional and multicultural team setting.
The Safety Science Director will consult with physicians in Safety Science, as needed, for medical input on safety issues.
Product Development Safety Risk Management :
Develop timely and scientifically sound clinical safety portions of a Product Development Plan (PDP), 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)
Contribute to development the product safety strategy and provide drug safety input into the Clinical Development strategy aligned with the safety strategy and risk management plans (e.
g., Integrated Safety Management Plan (ISMP), RMP)
Review of clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication
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 a safety science physician.
Accountable for signal detection, evaluation and decision-making across the lifecycle of the product.
Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable
Prepare and present (or 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
Pharmacovigilance (PV) and Risk Management :
Contribute to the ongoing PV and Risk Management planning for designated products by preparation of the safety surveillance strategy
Contributes to the development and oversight of the signal detection plan (SDP) and the signal detection and assessment activities
As assigned, support the Safety Science Leader or Director / Group Head, Safety Science or be responsible for the development of the RMP / ISMP or Risk Evaluation and Mitigation Strategies (REMS) for submission to regulatory health authorities (HA)
Prepare and review periodic aggregate safety reports (Periodic Benefit Risk Evaluation Report / PBRER, Periodic Safety Update Report / PSUR, EU renewal and other Safety Reports) and benefit-risk assessments
Support the preparation and maintenance of safety sections of the Company Core Data Sheet and / or Reference Safety Information in the IB
Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (product quality) or in response to HA requests
May be expected to support non-molecule projects, due diligence evaluations and other projects as needed.
Will work in partnership with CSSD team members to meet Safety Science deliverables
Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures and other guidelines.
Additional responsibilities of a Director, Safety Science :
Contribute and / or lead the development of the safety components of the Target Product Profile (TPP), key claims and other lifecycle strategic planning documents (e.
g., the Clinical Development Plan / CDP, Integrated Development and Commercialisation Process / IDCP, etc.). Responsible for the safety components and co-
responsibility for the benefit / risk components together with the Clinical representative
Develop and maintain comprehensive product safety strategy
Contribute to the CDP throughout the exploratory and confirmatory phase together with the Clinical representative in order to optimise the benefit / risk profile
Accountable for the safety components of study reports, aggregate reports and high level regulatory documents
Acquire and contribute knowledge of relevant drug class and / or competitor safety issues. Lead development of the safety surveillance strategy, identify potential clinical safety issues and recommend appropriate safety monitoring measures
Lead the development of scientific publications (abstracts, posters, papers) for scientific meetings / journals and approve the submissions from a safety perspective
Enable / facilitate the transition of appropriate drug candidates from exploratory to confirmatory development for all aspects pertinent to safety.
Assume similar responsibilities for the transition of products from LCT stage to mature stage when there are no longer any global clinical development activities nor any significant clinical development
Education, Skills and Experience (Minimum : )
Bachelor’s Degree in life sciences required; Advanced Clinical / Science Degree preferred (e.g., PharmD, PhD, MSN, MPH, DDS, DVM, etc.)
Experience of drug safety, clinical development or medical affairs experience in the pharmaceutical or related industry
Experience in the principles and techniques of data analysis, interpretation and clinical relevance
Understanding of GxP and regulated processes and end-to-end clinical trial lifecycle
Strong orientation towards cross-functional teamwork
Effectively work with remote partners on a global team
Excellent written and verbal English communication skills
In Pharma Development, we recognise that we are working in a global environment with teams located across multiple sites and time zones.
As such, we allow flexibility in terms of contractual working hours to enable you to deliver project work whilst maintaining a work life balance and we encourage line managers to support these aims in discussion with their staff.
If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you.
In return we offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation, including a genuine interest in your development and progression.
To be considered for this position, please apply using the link below.
When completing your application, please ensure you attach an up to date CV and details of your current remuneration package.
This role is a band 3
We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche!
Who we are At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-
focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer.