at Cytokinetics (View all jobs)
South San Francisco, California
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. The Senior Drug Safety Case Manager will independently support the Drug Safety Department. The candidate will work in a role of leadership in development, implementation, and maintenance of a quality system for all Drug Safety activities, encompassing processes, procedures, compliance, and metrics.
- Assist in overseeing the CRO processing SAE reports on Cytokinetics products in accordance with all applicable regulations, guidelines, and SOPs with little or no supervision. This includes detailed review of source documentation, assessing cases for reportability, generation of analysis of similar events, quality check, and overseeing preparation of applicable aggregate safety reports.
- Evaluate project or case workflow and offer solutions for process improvement
- Maintain regulatory and department compliance by ensuring timely completion of reports and assisting in submissions of reportable cases to regulatory agencies (if needed), study investigators, and licensing partners
- Represent the Drug Safety Department in cross-functional team meetings, as needed
- Support coding review of medical history, adverse events, and concomitant medications
- Conduct periodic reconciliation of SAEs between the drug safety and clinical trial databases for ongoing clinical studies.
- Draft and update departmental SOPs and other work practices as assigned and maintain consistency with regulatory guidelines and good pharmacovigilance practices
- Participate in training internal and external audiences on drug safety-related topics, as assigned.
- Guide departmental policies and procedures by maintaining a high level of understanding of federal and international regulations
- Draw upon the knowledge of Drug Safety regulations & practices, disease-specific clinical knowledge and understanding of corporate objectives to solve complex problems in creative and effective ways as well as to anticipate routine problems and mitigate them without supervisory intervention
- BS degree in a life science discipline (e.g., pharmacy, or nursing) with 5+ years of relevant experience
- Broad knowledge of domestic and international drug safety regulations, industry practices and standards
- Must have a strong attention to detail, teamwork and initiative
- Must have excellent written and oral communication skills, resourcefulness and personal organization skills
- Excellent working knowledge of MedDRA and WHODRUG coding dictionaries.
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
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