Director, Drug Safety Operations - Cytokinetics : Job Details

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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.This position will provide leadership and direction to the Drug Safety operations for adverse event case management, support of study teams and projects, oversight of maintenance of drug safety database, and collaboration to support risk management and pharmacovigilance for all Cytokinetics clinical trials.Responsibilities

• Manage SAE/SUSAR reporting activities for all investigational drugs
• Manage preparation and processing of internal and external SAE reports
• Review incoming adverse events to determine action required
• Oversee maintenance of a hosted electronic database for tracking, storing, and reporting serious adverse events from Cytokinetics clinical trials.
• Ensure corporate compliance with domestic and international adverse event reporting requirements for all products in worldwide development programs
• Collaborate with partners on the exchange of safety data, safety monitoring, and the safety profile of investigational drugs as defined in Pharmacovigilance Agreements
• Lead preparation of safety-related plans with partners and CROs
• Provide guidance and support to project teams for safety-related areas, including protocol development and study conduct
• Contribute to preparation of relevant sections of clinical study reports, annual reports, expedited safety reports and other regulatory filing documents
• Coordinates pharmacovigilance Quality Auditing preparation
• Coordinates root cause analysis and implementation of corrective action and preventing action (CAPA) after internal audits and inspections
• Assist with preparation and updates to Investigator Brochures, DSURs, Protocols, ICFs, etc.
• Train staff and external CRO's on drug safety principles and procedures
• Manage and mentor staff and assign responsibilities as appropriate to meet timelines and quality metrics
• Respond to safety-related queries from regulatory authorities or Ethics Committees, if needed
• Collaborate to ensure alignment among case handling, aggregate reporting, and signal detection activities

Qualifications

• Advanced degree in life sciences, nursing, pharmacy, or medicine
• 10+ years pharmaceutical industry drug safety experience
• Knowledge of and experience with international regulatory adverse event reporting requirements
• EudraVigilance electronic reporting of ICSRs experience
• Hands-on experience with adverse event case processing
• Proven experience and effectiveness at training and mentoring drug safety staff
• Excellent knowledge of MedDRA coding and WHODrug coding
• Ability to work independently, establish functional priorities and execute on goals
• Excellent interpersonal communication skills and ability to work effectively as part of teams
• Experience in neurology and/or cardiovascular drug development desirable

Pay RangeIn the U.S., the hiring pay range for fully qualified candidates is $251,800.00- $278,300.00 USD Annual USD per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.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 OffersRecently, 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 [email protected]

Please visit our website at: www.cytokinetics.comCytokinetics is an Equal Opportunity Employer

Seniority level

• Seniority levelDirector

Employment type

• Employment typeFull-time

Job function

• Job functionManagement and Manufacturing

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