Roche · 19 hours ago
US Patient Safety, Sr. Scientist
United States
Full-time
Remote
Mid, Senior Level
$100K/yr - $225K/yr
3+ years expRoche is a leading healthcare company, and they are seeking a US Patient Safety Sr. Scientist to manage safety activities in collaboration with cross-functional groups. The role involves ensuring compliance with health authority regulations, overseeing protocol management, and providing pharmacovigilance oversight for therapeutic areas.
BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
Responsibilities
You will be responsible for maintaining compliance with health authority regulations and guidance documents pertaining to ICSR submissions, clinical trial protocol management, safety data exchange agreements, as well as PV agreements; for the oversight and implementation of internal Manuals, global/local safety SOPs/Work Instructions (applicable to US PS), external collaborations agreements, e.g., PVAs and SDEAs; identifying and creating additional, or updating existing local Guidance Documents, including but not limited to training matrices, and identifying the appropriate target audience for training assignment
You will bring expert knowledge of protocol management in accordance with PV-related standards, regulations, and Genentech/Roche Standard Operating Procedures (SOPs) in order to oversee and lead the protocol review process for sponsored/managed and supported/funded studies for molecules/products in assigned therapeutic areas
You will be accountable for providing PV oversight to appropriate study/molecule teams, including for Post Authorization Safety Assessment (PASS) classification for all Genentech /Roche sponsored and supported studies based on medical knowledge and European Union (EU) regulations
You will review Safety Data Exchange Agreements and Safety Management Plans (as applicable) and provides guidance on related documents
You will be responsible for specific therapeutic area assignments and tracking
You will actively participate as a member of the Study Management Team and performs PV activities including, but not limited to, providing safety reporting training for investigator meetings, acts as a single point of contact for safety related concerns, and acts as a safety liaison between clinical safety, Study Review Team (SRT), Study Management Team (SMT), and any similar governing bodies; additionally, you will be responsible for the determination of safety language for Non-interventional studies and research projects
You will act as a single point of contact for safety-related issues/concerns; you will oversee safety-related activities for assigned Genentech/ Roche Product(s) managed by US Medical. You will act as the Safety Liaison between Clinical Safety and the Medical Team
You have the ability to demonstrate advanced knowledge of the safety profile to include comprehensive working knowledge of appropriate labeling documents for assigned Genentech/ Roche Product(s)
You will provide the medical team molecule support in appropriate safety areas
You will advise the medical teams conducting interventional or non-interventional research that improves the care of patients from a safety perspective; Responsible for ensuring oversight and appropriate classification of all activities under USM
You will exhibit total knowledge of study classification (i.e., interventional studies, non-interventional studies, post-approval safety studies (PASS), registries, etc
You will become an expert of the Genentech/ Roche Product(s) safety profile(s) and appropriate labeling documents; you will provide guidance on the medical review of safety-related documents, including but not limited to pregnancy letters, and develops a plan of action to mitigate any risk; you will prepare written responses to drug safety queries from Health Care Professionals using the locally available information and/or initiating literature searches as required, and/or initiating an investigation by Patient Safety Contact Line (global) as needed
You will be responsible for the implementation of Risk Management Plans (RMP) / Risk Minimization activities or Risk Evaluation and Mitigation Strategies (REMS) for assigned molecules/products, with the ability to function as the RMP IC (as required)
You will manage all PV-related activities or commitments that are appropriately actioned for assigned therapeutic areas, which include, but are not limited to, overseeing all study activities performed by the individual molecule responsible
You will participate in the preparation of abstracts, posters, and presentations for medical/ scientific meetings and/or congresses based on the collaborative initiatives
You will work closely, providing support where needed, with assigned US PS Medical Network Lead(s) to be aware of any safety issues/concerns and assist, or lead special projects as assigned by and under the direction of the US Patient Safety (Associate) Group Director and/or other Safety personnel
Qualification
Required
You are an experienced health care professional (HCP) with formal research training (e.g. MD, PharmD, DNP, DMSc, non-doctorate HCP with MPH, MS or PhD)
You have 3+ years of pharmaceutical/biotechnology experience
You have a demonstrated understanding of and/or previous experience with Phase I-III and/or Phase IV drug development; You have demonstrated experience designing/writing protocols, clinical studies
You have a high level of expertise in computer skills and database experience; you have a demonstrated experience in the principles and techniques of data analysis, interpretation, and clinical relevance, and medical writing
You have demonstrated experience using a safety database (e.g. ARIS, ARGUS, LSMV)
You have experience working in a cross functional/matrix environment
Preferred
You have demonstrated strong interpersonal and communication skills with the ability to communicate technical knowledge in a clear and understandable manner, especially to non-experts; you excel at problem-solving skills and the ability to work under ambiguous situations
You have excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities; you complete work in a timely, accurate and thorough manner
You have the ability to travel as per business needs
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
Company
Roche
Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases.
10001+ employees
H1B Sponsorship
Roche has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (9)
2023 (6)
2022 (2)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$7.79BKey Investors
SoftBankSCALE AINovartis
2021-08-04Post Ipo Equity· $5B
2020-12-07IPO
2020-05-06Post Ipo Equity· $0.5M
Leadership Team
Alan Hippe
Member of the Executive Board - Group CFO
Christine Bakan
Global Head and Group Vice President, Computational Science and Informatics R&D
Recent News
2026-01-25
2026-01-23
2026-01-22
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