Drug Safety Case Manager
Location: South San Francisco, California
Job Category: Pharmacovigilance
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About Cytokinetics:
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors. The company is committed to creating treatments for debilitating diseases where cardiac muscle performance is compromised, leveraging its leadership in muscle biology and mechanics.
The Position:
The Drug Safety Case Manager will support the day-to-day functioning of the Drug Safety Department. This role includes a key position in the development, implementation, and maintenance of a quality system for all Drug Safety activities, covering processes, procedures, compliance, and metrics.
Responsibilities:
Ensure all safety reports for Cytokinetics’ products are processed in the safety database and reported according to ICH-GCP guidelines, regulatory requirements, and company SOPs.
Assist in overseeing CROs processing SAE reports on Cytokinetics products, including reviewing source documentation and assessing cases for reportability.
Process adverse event-related information in the safety database, including writing narratives for expedited and non-expedited reports.
Coordinate follow-up for missing or ambiguous safety data.
Coordinate production of safety data outputs for analyses and reports.
Maintain compliance by ensuring timely completion of reports and assisting in submissions to regulatory agencies and study investigators.
Participate in Study Operation Team meetings and lead PV-related study activities, including developing study-specific Safety Management Plans and training project-team members.
Liaise with other functional groups for cross-functional PV processes such as SAE data reconciliation.
Evaluate workflows and propose solutions for process improvements.
Represent the Drug Safety Department in cross-functional team meetings as needed.
Conduct periodic reconciliation of SAEs between safety and clinical trial databases.
Draft and update departmental SOPs and work practices.
Participate in training internal and external audiences on drug safety topics.
Maintain a high understanding of federal and international regulations and guide departmental policies accordingly.
Assist in the preparation of periodic safety reports and safety data presentations.
Mentor and support departmental team members for high-quality execution of daily activities.
Act as a Subject Matter Expert (SME) for safety-related activities.
Participate in the creation and implementation of department strategies, goals, and new safety initiatives.
Qualifications:
Degree in life sciences; healthcare professional qualification (pharmacy, nursing, or equivalent) strongly preferred.
3 to 5 years of experience in drug safety with broad exposure to PV-related activities, including ICSR activities and periodic reports.
Broad knowledge of domestic and international drug safety regulations, industry practices, and standards.
Experience with drug safety databases (e.g., Argus, ARISg).
Excellent working knowledge of MedDRA and WHODRUG coding dictionaries.
Ability to work independently and collaboratively under minimal supervision with urgency in a dynamic, cross-functional environment.
Proficiency in MS Word, Excel, PowerPoint, and Outlook.
Strong interpersonal, written, and oral communication skills.
Strong organizational skills, attention to detail, and adaptability in a fast-paced environment.
Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $150,100 - $165,900 USD per year. Base pay will vary based on geographic region, knowledge, skills, and experience.
Diversity and Inclusion Statement:
Cytokinetics celebrates differences and encourages applicants from all backgrounds. Applicants are not expected to meet every qualification listed and are encouraged to apply if they believe they can add value to the team.
Fraud Alert:
All legitimate Cytokinetics offers will come from the official Cytokinetics.com domain. Interviews will not be conducted through non-standard text messaging applications. Cytokinetics will never ask for banking details before an official offer is accepted or request the purchase of equipment during hiring.
For questions about authenticity, contact: talentacquisition@cytokinetics.com
For more information, visit: www.cytokinetics.com
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