Drug Safety Case Manager

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 as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

Job Description:

Job purpose

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.

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.

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.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications
• We will never request personal information such as banking details until after an official offer has been accepted and verified
• We will never request that you purchase equipment or other items when interviewing or hiring
• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer