Director, Drug Safety Physician

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.

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)

Qualifications

• 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)

• 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

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Pay Range:

In the U.S., the hiring pay range for fully qualified candidates is $264,600-$308,700 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidat