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.
The Drug Safety & Pharmacovigilance Physician provides medical, scientific, and strategic leadership for pharmacovigilance and risk management activities for assigned investigational and commercial products. The position supports continuous evaluation of product safety profiles through medical review of individual and aggregate safety data, signal detection and management, benefit-risk assessment, and regulatory safety reporting.
Working collaboratively with Drug Safety and Pharmacovigilance colleagues, cross-functional project teams, external service providers, and partner companies, the physician ensures that safety activities are medically sound, timely, inspection-ready, and conducted in accordance with applicable global requirements, internal procedures, and contractual agreements.
Essential Job Duties and Responsibilities
Product Safety and Medical Leadership
- Serve as the medical safety lead for assigned products and development programs, providing medical and scientific input into safety surveillance, risk assessment, and ongoing benefit-risk evaluation throughout the product lifecycle.
- Contribute to product-specific safety strategies, safety management plans, risk management activities, and pharmacovigilance policies and procedures.
- Identify, assess, escalate, and communicate important or emerging safety findings, and recommend additional evaluation, monitoring, risk minimization, or regulatory action, as appropriate.
- Participate in Safety Management Teams and other cross-functional governance forums; prepare and present clear safety analyses, conclusions, and recommendations.
Medical Review and Case Assessment
- Conduct medical review of individual case safety reports from clinical trials, spontaneous reports, solicited sources, scientific literature, and other relevant sources.
- Assess seriousness, expectedness, causality, medical significance, reportability, and consistency with the evolving product safety profile.
- Analyze and assess suspected unexpected serious adverse reactions, critical cases, adverse events of special interest, designated medical events, and other events requiring enhanced medical review or follow-up.
- Provide medical and strategic input into adverse event coding, case processing, follow-up strategy, and preparation of expedited safety reports.
- Identify medically related cases and conduct or contribute to analyses of similar events, case series evaluations, and cumulative case reviews.
- Signal Detection and Safety Evaluation
- Perform signal detection and signal management activities using individual case reports, aggregate analyses, clinical and nonclinical data, literature, product quality information, and other internal and external data sources.
- Evaluate potential and validated signals, safety trends, and watchlist topics, considering strength of evidence, temporal relationship, biological plausibility, dechallenge/rechallenge, confounding factors, alternative etiologies, exposure, and class effects.
- Conduct systematic reviews of aggregate safety data and prepare signal assessments, cumulative reviews, safety evaluation reports, and benefit-risk evaluations.
- Coordinate follow-up and further evaluation of critical cases, adverse events of special interest, and events associated with identified or potential risks.
- Document signal activities, decisions, recommendations, and closure rationale in accordance with applicable procedures and regulatory requirements.
Aggregate Reports and Regulatory Documents
- Author, review, and approve, as delegated, safety content for clinical study protocols and amendments, informed consent forms, Investigator Brochures, Reference Safety Information, and clinical study reports.
- Contribute to Development Safety Update Reports, PBRERs/PSURs, IND annual reports, integrated summaries of safety, marketing applications, Risk Management Plans, Company Core Data Sheets, health authority responses, and other regulatory submissions.
- Ensure that safety conclusions are medically sound, balanced, evidence-based, and consistent across relevant clinical, safety, labeling, and regulatory documents.
- Assess whether new safety information warrants changes to clinical trial documents, core safety information, product labeling, monitoring plans, risk management activities, or risk minimization measures.
- Cross-Functional and External Collaboration
- Provide medical safety input to Clinical Development and study teams on protocol design, eligibility criteria, adverse events of special interest, safety monitoring, stopping rules, and data collection strategies.
- Collaborate with Regulatory Affairs, Medical Affairs, Biostatistics, Clinical Operations, Data Management, Quality, and other functions to support appropriate interpretation and communication of safety information.
- Work with alliance partners, license partners, contract research organizations, vendors, and investigators on safety surveillance, case evaluation, signal management, aggregate reporting, and issue resolution.
- Contribute to the development, review, implementation, and maintenance of Safety Data Exchange Agreements and other pharmacovigilance agreements.
- Provide pharmacovigilance training and medical guidance to internal personnel and external service providers, as needed.
- Compliance and Inspection Readiness
- Ensure assigned pharmacovigilance activities comply with applicable FDA, EMA, ICH, and other global requirements, internal procedures, regulatory commitments, and contractual timelines.
- Maintain complete, accurate, traceable, and inspection-ready documentation of medical reviews, signal evaluations, safety decisions, and related activities.
- Participate in internal audits, partner audits, mock inspections, health authority inspections, and preparation of responses and corrective and preventive actions, as applicable.
- Identify process gaps and compliance risks and contribute to continuous improvement of pharmacovigilance procedures, tools, training, and governance processes.
- Maintain current knowledge of evolving pharmacovigilance regulations, safety science methods, therapeutic-area literature, and industry practices.
Qualifications
Education and Professional Credentials
- MD, DO, or equivalent medical degree required.
- Completion of postgraduate clinical training required; board certification or board eligibility preferred.
- Active or previously active medical licensure preferred.
Experience
- Minimum of 5 years of relevant pharmaceutical or biotechnology industry experience, including substantial experience in pharmacovigilance, drug safety, clinical development, or a related medical function.
- Demonstrated experience in medical case review, signal detection and evaluation, aggregate safety assessment, and benefit-risk evaluation.
- Experience supporting global development programs required; experience with commercial or postmarketing products preferred.
- Experience authoring or reviewing DSURs, PBRERs/PSURs, Investigator Brochures, Reference Safety Information, clinical study reports, integrated summaries of safety, Risk Management Plans, or marketing applications.
- Experience collaborating with cross-functional teams, partner companies, contract research organizations, and pharmacovigilance vendors.
- Cardiovascular and/or neurology clinical or drug development experience desirable.
- Knowledge, Skills, and Competencies
- Strong knowledge of global pharmacovigilance regulations, safety reporting requirements, Good Clinical Practice, and signal management principles, including applicable FDA, EMA, and ICH requirements.
- Strong clinical judgment and ability to interpret complex individual and aggregate safety data in the context of disease, patient population, concomitant treatment, exposure, and the overall product benefit-risk profile.
- Ability to distinguish safety observations, potential signals, validated signals, adverse drug reactions, and important identified or potential risks using a structured, evidence-based approach.
- Excellent scientific and regulatory writing skills, with the ability to prepare clear, concise, medically accurate, and defensible safety assessments.
- Excellent verbal communication, collaboration, and influencing skills, including the ability to communicate complex safety information to scientific, operational, executive, and external audiences.
- Ability to work independently, exercise sound medical judgment, appropriately escalate significant issues, manage competing priorities, and meet demanding timelines in a dynamic environment.
- Proficiency with standard business applications; familiarity with safety databases, signal management tools, and medical coding dictionaries, including MedDRA, preferred.
Other Requirements
- This position may require occasional domestic or international travel and participation in meetings across global time zones. Additional duties may be assigned based on business needs and the evolving product portfolio.
#LI-REMOTE
Pay Range:
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.
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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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Cytokinetics is an Equal Opportunity Employer
