Job Description
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, Drug Safety Physician is responsible for managing important pharmacovigilance activities for the company, including the detection and analysis of safety issues for investigational drug 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 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 - Under the direction of the Senior Director of Drug Safety and Pharmacovigilance, 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 investigational 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
- Contributes 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 products
- Review and summarize scientific literature relevant to pharmacovigilance on assigned projects
- Participate in in inspection readiness activities and preparation as needed
- Stay current with international pharmacovigilance requirements and guidelines (focus on FDA and EMA)
Qualifications - MD or equivalent, PharmD, or advanced degree in nursing
- 7+ 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 neurology and/or cardiovascular drug development desirable
Pay Range: In the U.S., the hiring pay range for fully qualified candidates is $251,800 - 278,300 USD Annual 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 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: Cytokinetics is an Equal Opportunity Employer
Job Tags
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