Director, Drug Safety Physician

Cytokinetics•South San Francisco, CA

1d•$264,600 - $308,700•Hybrid

About The Position

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. At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact. The Director, Drug Safety Physician is responsible for leading global pharmacovigilance activities for the company, including risk management activities for investigational and marketed medicinal products in compliance with global pharmacovigilance and regulatory requirements. The position provides medical and strategic input for adverse event monitoring, coding, and signal detection to ensure that global PV regulatory requirements for case reporting and management are met. The position will report to the Senior Director, Drug Safety and Pharmacovigilance and will work collaboratively within the Drug Safety and Pharmacovigilance department, across departments, and with partner companies to achieve PV and company goals.

Requirements

MD (or equivalent) or PharmD
8+ years of drug safety experience (with 5+years managing medical case review and signal detection)
Strong knowledge and understanding of international safety reporting and pharmacovigilance requirements and signal detection
Ability to take initiative yet work collaboratively on multiple projects and with partner companies to achieve goals in compliance with PV and regulatory requirements and safety data exchange agreements
Excellent written and oral communication skills
Excellent interpersonal skills and ability to work effectively as part of a team(s)

Nice To Haves

Experience in cardiovascular drug development desirable
Strong knowledge and understanding of international safety reporting and pharmacovigilance requirements and signal detection
Ability to take initiative yet work collaboratively on multiple projects and with partner companies to achieve goals in compliance with PV and regulatory requirements and safety data exchange agreements
Excellent written and oral communication skills
Excellent interpersonal skills and ability to work effectively as part of a team(s)
Experience in neurology and/or cardiovascular drug development desirable

Responsibilities

Perform signal detection activities to ensure signal identification and evaluation, including individual and aggregate data analyses, interpretation of safety signals and trends, and documentation and communication of safety assessments for all company medicinal products
Participate in safety surveillance strategy and activities for all Cytokinetics’ medicinal products, including development and implementation of relevant policies and procedures
Lead Safety Management Team (SMT) and conduct meeting(s) to evaluate risk-benefit for medicinal products with support from cross-functional teams. Escalate and present safety issues to senior management in company governance meetings
Conduct medical review of individual case safety reports
Contribute to the creation of analysis of similar events
Collaborate with partners on safety monitoring and signal detection and risk management activities
Participate in establishing and maintaining Safety Data Exchange Agreements
Collaborate, contribute to and review relevant sections of clinical and regulatory documents, including protocols, informed consent forms, study reports, integrated summaries of safety, expedited safety reports, DSURs marketing applications and other regulatory submission documents on assigned projects
Contribute to the creation and maintenance of Reference Safety Information, and the safety sections of Investigator Brochures, company core data sheets and applicable country labels for all investigational and marketed products
Review and summarize scientific literature relevant to pharmacovigilance on assigned projects
Participate in inspection readiness activities and preparation as needed
Provide recommendations and guidance by staying current with international pharmacovigilance requirements and guidelines (focus on FDA and EMA)