Summary of Position:
The PV Clinical Scientist - ICSR Case Management performs the tactical and operational job responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Patient Safety (USPS). The PV Clinical Scientist - ICSR Case Management performs clinical review of USPS cases (processed in-house or externally by the vendor) and supports the US Patient Safety PV Clinical Manager - ICSR Case Management in all activities. All responsibilities are performed under the direction of the PV Clinical Manager - ICSR Case Management.
Key Accountabilities:
• Completes patient safety monitoring and tracking in a timely, thorough and accurate manner in
accordance with pharmacovigilance (PV) and related standards, regulations and Genentech/Roche
Standard Operating Procedures(SOPs)
o Reviews, evaluates, and verifies potential AE information during triage to determine required action
per internal policies and procedures and perform data entry of adverse event by timely completion of
the case via Roche global safety database. Performs seriousness / validity/causality assessments and
conducts quality review of all cases (as applicable) based on their medical assessment
o Performs labeling assessment for AE(s) received using clinical knowledge and conducted follow up for
all reported cases (as applicable)
• Responsible for Clinical Review of cases processed in-house and by vendors
o Understands case processing data to evaluate error rates and potential compliance impact
o Responsible for training internal USPS and/or vendors staff or team in collaboration with SP PV
oversight based on trend analysis
o Responsible for ensuring appropriate data correction in the safety database for identified issues or
errors
• Responsible for maintaining follow-up templates, ensuring successful transmission of all follow-up
attempts performed by PV Clinical Scientist - ICSR Case Management/Vendor staff via the
communication module
o Accountable for training internal and external staff members on using communication module
o Performs daily reconciliation of outgoing communications
• Supports PV Clinical Scientist - Product in tasks and projects as needed
• Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience
(as needed)
• Assists in AE reconciliation activities and/or Case Transmission Verification (CTV) (as applicable)
• Acts as single point of contact with key stakeholders for safety-related activities, identifies potential
business gaps and assists in the development and implementation of process solutions, and leads
projects as assigned and under the direction of the US Patient Safety management
Responsible for the preparation and development of Patient Safety presentations and participates in the
education offer internal /external stakeholders as applicable
• Acts as Subject Matter Expert (SME) for safety-related activities within Global Safety Database per
Genentech/Roche SOPs
• Provide support during audits and inspections
•Collaborates with PV Operations and SP PV Oversight teams as needed
Competencies Identified for Success:
• Demonstrates capability to comprehend medical information
• Demonstrates ownership, initiative and accountability
• Sound decision-making abilities as demonstrated by systematic gathering of information, appropriately
assessing the complexity of issues, and prioritization of tasks in a timely manner within the scope of
responsibility
• Ability to follow direction / guidance from USPS leadership or colleagues as required
• Works well independent or within teams and is effective in collaborating with others internally and
externally
•Communication and presentation skills; highly effective at summarizing and presenting key
considerations and decision-points
•Strong attention-to-detail
• Able to travel local / international as per business needs
Education, Experience, and Other Requirements:
• Health Care Professional degree (e.g., RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, or MD) (Required)
• Minimum 5 - 7 years of clinical / Pharmacovigilance experience or 3 - 5 years with Masters or 0-2 years
with PhD (Required)
• Writing experience; science/medical writing (Required)
• Computer proficiency (Required)
• Data entry experience (Preferred)
• Project Management (Preferred)
Pay Range: $50 - $50/hour
- Health, Dental, Vision, 401k
Location: This position is remote but the candidate should be in PST.
