The Clinical Safety Associate I (CSA I) supports the drug safety staff in the day to day operational job responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Drug Safety. The CSA I supports study management activities in collaboration with other functional groups and supports the US Drug Safety Case Management Manager (CMM) in all activities. All responsibilities are performed under the direction of the CMM.
Reviews, evaluates and verifies potential AE information to determine required action per internal policies and procedures
Provides medical assessment on all cases for seriousness / validity / causality and conducts quality review of all cases (as applicable) including medical review of information entered in the safety database for completeness and coherency
Performs follow up (e.g. Drug specific questionnaires / Pregnancy reports etc.) for all reported cases (as applicable) based on their assessment (i.e. Medically significant, non-serious, invalid etc.) to capture complete medical picture of an ICSR
Medically reviews ancillary documentation accompanying Individual Case Safety Reports (ICSRs) and identifies medically relevant safety information for incorporation into the Global Safety Database
Demonstrates understanding of appropriate labeling documents for Genentech/ Roche molecules and products and performs labelling assessment for AE(s) received using clinical knowledge
Identifies and collaborate with external stakeholders for Antibody testing requests
Responsible for identifying ICSRs requiring expedited safety reporting to Health Authorities. (~5%)
Responsible for review and implementation of internal Manuals, global / local safety SOPs / Work Instructions (applicable to USDS). Identify the need for creating additional or updating existing local Guidance Documents including but not limited to training matrix and identify appropriate target audience for training assignment. (~3%)
Demonstrates a general understanding of protocol management in accordance with PV related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs) to support the protocol review process for supported/funded studies (~10%)
Perform Post Authorization Safety Assessment (PASS) classification for all Genentech /Roche supported studies based on medical knowledge and European Union (EU) regulations
Assists in reviewing Safety Data Exchange Agreements (as applicable)
Participates and supports the Supported Research Team (as applicable)
Assists in AE reconciliation and/or Case Transmission Verification (CTV) activities (as applicable)
Acts as single point of contact for safety related issues
Acts as Safety Liaison between Safety Science and Supported Research Team
Oversees Safety related activities for assigned Genentech/ Roche Product(s) managed by US Medical Affairs to include (~10%)
Demonstrates advanced knowledge of the safety profile to include comprehensive working knowledge of appropriate labeling documents for assigned Genentech/ Roche Product(s)
Communicates and updates Team of any process related issues/ concerns
Acts as single point of contact for safety related concerns
Acts as Safety Liaison between Safety Science, Supported Research Teams (SRT) and Medical Team
Responsible for medical review and updating of safety sections for documents e.g. pregnancy letters and notify appropriate stakeholders of any changes in executive summary of aggregate reports
Assist in implementation of Risk Management Plans (RMP) / Risk Minimization activities or Risk Evaluation and Mitigation Strategies (REMS) for assigned molecules / products
Assists in projects under the direction of US Drug Safety management or project lead (~10%)
Contribute to the preparation and development of Drug Safety presentations for internal/external stakeholders as applicable (~2%)
Liaise with Compliance and Training (CAT) / Business Operations Analytics and Market Research and Patient Support (BAM) teams within USDS to ensure all processes are implemented
Supports the onboarding and training of new personnel
Provides support during audits and inspections
Acts as Subject Matter Expert (SME) for safety related activities within Global Safety Database per Genentech/Roche SOPs
Competencies Identified for Success:
Demonstrates capability to comprehend medical information
Works effectively, independently and collaboratively
Strong organizational skills, detail oriented and adapts in a fast paced, changing environment
Demonstrates ownership, initiative and accountability
Excellent communication skills, both written and verbal
Ability to prioritize tasks in a timely manner
Ability to interact effectively in a multifunctional, multidisciplinary team setting
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