US Patient Safety, Sr. Scientist

Roche

5d•$100,000 - $225,000•Remote

About The Position

The US Patient Safety Sr. Scientist is responsible for the study management safety activities in their assigned therapeutic area in collaboration with other cross-functional groups and serves as the US safety single point of contact along with Pharma Development Clinical Safety, operating under the guidance of the US Patient Safety (Associate) Group Director in all activities. The US Patient Safety (Associate) Group Director guides and supports the product-specific case evaluation and strategy for adverse events received by US Patient Safety. 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. This is a US based remote position. Relocation benefits are not being provided.

Requirements

Experienced health care professional (HCP) with formal research training (e.g. MD, PharmD, DNP, DMSc, non-doctorate HCP with MPH, MS or PhD)
3+ years of pharmaceutical/biotechnology experience
Demonstrated understanding of and/or previous experience with Phase I-III and/or Phase IV drug development
Demonstrated experience designing/writing protocols, clinical studies
High level of expertise in computer skills and database experience
Demonstrated experience in the principles and techniques of data analysis, interpretation, and clinical relevance, and medical writing
Demonstrated experience using a safety database (e.g. ARIS, ARGUS, LSMV)
Experience working in a cross functional/matrix environment

Nice To Haves

Demonstrated strong interpersonal and communication skills with the ability to communicate technical knowledge in a clear and understandable manner, especially to non-experts
Excel at problem-solving skills and the ability to work under ambiguous situations
Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities
Complete work in a timely, accurate and thorough manner
Ability to travel as per business needs

Responsibilities

Study management safety activities in their assigned therapeutic area
Serves as the US safety single point of contact along with Pharma Development Clinical Safety
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
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
Oversee and lead the protocol review process for sponsored/managed and supported/funded studies for molecules/products in assigned therapeutic areas
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
Review Safety Data Exchange Agreements and Safety Management Plans (as applicable) and provides guidance on related documents
Specific therapeutic area assignments and tracking
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
Determination of safety language for Non-interventional studies and research projects
Act as a single point of contact for safety-related issues/concerns
Oversee safety-related activities for assigned Genentech/ Roche Product(s) managed by US Medical
Act as the Safety Liaison between Clinical Safety and the Medical Team
Demonstrate advanced knowledge of the safety profile to include comprehensive working knowledge of appropriate labeling documents for assigned Genentech/ Roche Product(s)
Provide the medical team molecule support in appropriate safety areas
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
Exhibit total knowledge of study classification (i.e., interventional studies, non-interventional studies, post-approval safety studies (PASS), registries, etc.
Become an expert of the Genentech/ Roche Product(s) safety profile(s) and appropriate labeling documents
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
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
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)
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
Participate in the preparation of abstracts, posters, and presentations for medical/ scientific meetings and/or congresses based on the collaborative initiatives
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