Sr. Clinical Safety Specialist
Company: Quantum Leap Healthcare Collaborative
Location: San Francisco
Posted on: May 15, 2022
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Job Description:
Job Description Salary: Job Description Position: Sr. Clinical
Safety Specialist Reports to: Sr. Manager, Clinical Safety The Sr.
Clinical Safety Specialist will provide partner oversight in
relation to Clinical Trial safety report collection and processing.
This position will collaborate with other functions (e.g., Clinical
Operations, Safety Working Group (medical monitoring), Data
Management, Biostatistics, enrolling sites and others) to ensure
consistency with regulations and with departmental goals and
objectives. Principal Responsibilities Support with setting the
safety operations strategy and establishing the safety report
collection standards and clinical safety workflow Oversee workflow
management and case prioritization to maintain compliance with
regulatory timelines Receive, triage and process adverse events
from clinical trials Perform initial assessment of seriousness,
expectedness, causality, and reportability in accordance with GPV
processes, regulatory requirements, and guidelines Perform data
entry and quality review of adverse event reports into the safety
database, including accurate coding of MedDRA terms and preparation
of case narratives Identify missing or discrepant information and
perform active case follow-up via verbal or written contact Review
expedited reports for submission to regulatory authorities and
ethics committees Serve as pharmacovigilance liaison and resource
to internal and external groups (e.g., Safety Working Group,
Quality Assurance, clinical development teams, etc.) Report metrics
and KPIs for Clinical Trial safety report collection to the Sr
Clinical Safety Manager Provide functional support / input
(questions, solutions, meetings) to set up and maintain strong
sustainable partner relationship Support the Sr Clinical Safety
Manager in onboarding and ongoing maintenance of partner status to
perform work (e.g., access, training, technology set-up) Perform
reconciliations between clinical, and safety databases Support
preparation and submission of annual reports, as needed Serve as
pharmacovigilance resource and subject matter expert during
inspections and audits Collaborating with external project leaders
and teams to develop solutions, provide appropriate training, and
monitor quality Provide the compliance group with root cause
analysis and CAPA for quality issues Assist with writing and
updating of SOPs and other guidance documents, in response to
process improvements or changing regulations Participate in
database projects and user acceptance testing, as needed, providing
insight from business user / case processing perspective Complete
projects and tasks consistent with corporate objectives Perform
other duties as assigned Contribute to the company culture of being
collaborative, respectful, transparent, ethical, efficient,
high-achieving, and fun Education and Experience BA/BS degree in
nursing, pharmacy, or other health care related profession or life
sciences required, advanced degree preferred Proficient
understanding of Pharmacovigilance-related regulations is required
Experience working with safety databases required 5 years---
experience in drug safety/Pharmacovigilance in pharmaceutical
industry setting or the equivalent required Experience interacting
with clinical third parties (e.g., clinical sites, independent
DMCs) is preferred Maintain understanding of and ensure compliance
with SOPs, WIs, global drug/biologic/device regulations, GCP, ICH
guidelines, Good Pharmacovigilance Practice (GVP) modules, and the
drug development process Working knowledge of PV Systems, such as
Oracle Argus Safety, ARISg, Veeva Safety or other safety databases
Proficient in Microsoft Office Suite (Word, Excel and PowerPoint),
Visio, email, and SharePoint (or other management/shared
content/workspace) Strong verbal, written and interpersonal
communication skills with study sites and internal staff Excellent
organization, prioritization, project management and delegation
skills; with strong attention to detail Work collaboratively in a
multidisciplinary team Able to occasionally work extended and/or
flexible schedule to meet deadlines Excellent time management
skills Recognize potential obstacles and develop solutions to
resolve them with minimal consequence within set timelines or
change direction if priorities are modified Make critical,
independent decisions and be accountable for actions within a
fast-moving environment Perform at high levels with limited
supervision and effectively partner with team members when
necessary
Keywords: Quantum Leap Healthcare Collaborative, San Francisco , Sr. Clinical Safety Specialist, Healthcare , San Francisco, California
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