Senior Director, Medical Safety & Pharmacovigilance

Location: Northern

## Senior Director, Medical Safety & Pharmacovigilance Apply locations:
South San Francisco, California time type:
Full time posted on:
Posted Yesterday job requisition :
R664

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 Senior Director, Medical Safety & Pharmacovigilance serves as the safety expert and global lead for pharmacovigilance and risk management s position is responsible for the global safety strategy and overall safety profile of investigational and marketed products. As Senior Director, Medical Safety & Pharmacovigilance, this person will be responsible for oversight of PV and Drug Safety staff in managing the safety assessment of products, including review of individual and aggregate AEs, signal detection, preparation of safety reports, and risk management activities, and will work collaboratively with project teams and outside partners.
** Responsibilities
* ** Provide strategic and medical leadership for global safety surveillance and risk management activities across all investigational and, as applicable, marketed products, ensuring proactive benefit-risk assessment throughout the product lifecycle.
* Lead the development, implementation, and continuous improvement of pharmacovigilance policies, procedures, and safety governance processes that support regulatory compliance and operational excellence.
* Ensure compliance with global pharmacovigilance regulations and reporting requirements, including FDA, EMA, ICH, and other applicable health authority standards.
* Serve as the medical lead for signal detection and signal management activities, including identification, evaluation, interpretation, and communication of emerging safety signals through review of individual case reports, aggregate safety data, clinical trial data, literature, and external sources.
* Conduct and oversee medical review of serious adverse events, adverse events of special interest, and individual case safety reports to ensure accurate medical assessment and regulatory reporting.
* Chair and lead Safety Management Team (SMT) meetings and other safety governance forums, driving timely safety decision-making and escalation of significant safety issues.
* Author, review, and approve safety assessments, benefit-risk evaluations, signal evaluation reports, and safety recommendations for internal stakeholders, regulatory authorities, and external partners.
* Provide strategic leadership and oversight for the preparation and review of aggregate safety reports and regulatory safety submissions, including DSURs, PBRERs/PSURs, IND annual reports, expedited safety reports, integrated summaries of safety, and marketing application documents.
* Direct the development and maintenance of core safety documents, including Investigator Brochures, Reference Safety Information (RSI), Company Core Data Sheets (CCDS), Safety Management Plans, and Risk Management Plans, as applicable.
* Partner closely with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and Clinical Operations to integrate safety perspectives into development strategy and regulatory interactions.
* Collaborate with alliance partners, licensors, CROs, and external vendors on pharmacovigilance operations, safety monitoring, signal management activities, and safety data exchange agreements.
* Represent Drug Safety and Pharmacovigilance in cross-functional governance committees, development teams, due diligence evaluations, and interactions with regulatory authorities.
* Build, develop, and…