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’ investigational products, including development and implementation of relevant policies and procedures Conduct medical review of individual case sa... more details
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.
The Director, Medical Safety/Pharmacovigilance is a role we will look to bring full-time late this year. As our Director, you will be 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 Head of 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’ investigational products, including development and implementation of relevant policies and procedures
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, and company core data sheets. 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 with 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
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.
Salary Pay Range
$248,000—$303,000 USD
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.
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