Sr. Clinical Safety Specialist

Company: Quantum Leap Healthcare Collaborative
Location: San Francisco
Posted on: May 15, 2022

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