Drug Safety Case Manager

Cytokinetics•South San Francisco, CA

2d•$135,630 - $158,235•Hybrid

About The Position

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.

Requirements

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.

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.