Drug Safety Case Manager

Cytokinetics, Inc.; South San Francisco (CA); On-site; USD 136,000 - 158,000; Full time

Benefits offered by this job

Stock options

RSUs

Health, dental, vision

401k with employer match

Learning stipends

Paid time off

Job summary

Cytokinetics, Inc. is seeking a Drug Safety Case Manager in South San Francisco to oversee safety reporting and maintain a compliant PV system.

You will process safety reports, manage SAE processing, and coordinate data reconciliation across safety and clinical databases under ICH-GCP guidelines. You will draft SOPs, train staff, and contribute to the safety governance by producing analyses and safety outputs for regulatory submissions while ensuring timely reporting and cross-functional

Qualifications

• 3 to 5 years of drug safety experience.
• Broad knowledge of domestic and international drug safety regulations.
• Experience with drug safety databases (Argus, ARISg).
• Strong knowledge of MedDRA and WHODRUG dictionaries.
• Proficiency in MS Word, Excel, PowerPoint, and Outlook.
• Excellent written and oral communication; cross-functional collaboration.

Responsibilities

• Process safety reports in the safety database per ICH-GCP guidelines and SOPs.
• Oversee SAE processing with CROs in compliance with regulations.
• Manage safety data reconciliation between safety and clinical databases.
• Draft and update SOPs; mentor teammates; train internal/external audiences.
• Produce safety data outputs for analyses and regulatory submissions.

Skills

Drug safety experience

Argus

ARISg

MedDRA/WHODRUG

MS Office

Communication skills

Education

Life sciences degree

Healthcare professional preferred

Tools

Argus

ARISg

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

The Drug Safety Case Manager will support the day-to-day functioning of the Drug Safety Department. The candidate will have a key a role in development, implementation, and maintenance of a quality system for all Drug Safety activities, encompassing processes, procedures, compliance, and metrics.

Responsibilities

Ensures that all safety reports received from any source for Cytokinetics' products are processed in the safety database and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs, Work Instructions, departmental procedures and business partner agreements Assists in overseeing the CRO processing SAE reports on Cytokinetics products in accordance with all applicable regulations, guidelines, and SOPs. This includes detailed review of source documentation, assessing cases for reportability, generation of analysis of similar events, quality check. Processes adverse event related information in drug safety database for Cytokinetics' products, including the writing of narratives for expedited and non-expedited reports. Coordinates follow up for missing or ambiguous safety data. Coordinates the production of safety data outputs from the Safety database for analyses and reports. Maintains regulatory and department compliance by ensuring timely completion of reports and assisting in submissions of reportable cases to regulatory agencies, study investigators, and licensing partners, as needed. Participates is Study Operation Team meetings for assigned studies and leads the PV-related study activities including preparation of study start-up activities (e.g., development of study-specific Safety Management Plans, training of internal /external project-team members in safety-reporting processes, development of safety report forms, safety data reconciliation, site initiation training activities) Liaises with other functional groups for implementation of PV-related processes requiring cross functional collaboration, such as SAE data reconciliation between Clinical and Safety databases. Evaluates project or case workflow and offers solutions for process improvement. May represent the Drug Safety Department in cross-functional team meetings. Conducts periodic reconciliation of SAEs between the drug safety and clinical trial databases for ongoing clinical studies. Drafts and updates departmental SOPs and other work practices as assigned and maintains consistency with regulatory guidelines and good pharmacovigilance practices. Participates in training internal and external audiences on drug safety-related topics, as assigned. Maintains a high level of understanding of federal and international regulations and guidance so as to guide departmental policies and procedures. Assists with the preparation of periodic safety reports as assigned Assists with preparation of safety data presentations for departmental meetings (e.g., Drug Safety Committee Meetings) Assists with the mentoring, training and support for departmental team members for high quality and consistent execution of daily activities in the Drug Safety Department Acts as Subject Matter Expert (SME) for safety related activities Participates in the creation of the department strategy, goals, and objectives, and assists in the implementation of new safety initiatives and new Health Authority safety requirements.

Qualifications

Degree in life sciences. Health care professional (pharmacy, nursing or equivalent) is strongly preferred 3 to 5 years of experience in drug safety with broad exposure to various 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 Demonstrated ability to work effectively, collaboratively under minimal supervision with a sense of urgency in a dynamic, cross-function matrix environment Proficiency in the use of relevant computer systems including MS Word, Excel, PowerPoint, and Outlook Strong interpersonal, written and oral communication skills and professionalism Strong organizational skills, detail oriented and adapts in a dynamic, fast-paced, environment.

Pay Range

The expected salary range for this position based on the primary location of South San Francisco, CA is $135,630-$158,235. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.

Our employees come from different backgrounds, and we celebrate those differences.

Cytokinetics is an Equal Opportunity Employer.

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.