Senior Director, Pharmacovigilance - Safety Science and Surveillance job at reputed company. in US National

Senior Director, Pharmacovigilance (Safety Science & Surveillance) Boston, Mass or Remote The Senior Director of Pharmacovigilance (PV), Safety Sciences & Surveillance, provides strategic and operational leadership for global safety surveillance activities across Kura’s clinical and post-marketing programs. This individual is responsible for signal detection and evaluation, benefit-risk assessment, and safety surveillance strategies, for reputed company’s products. This role ensures compliance with global pharmacovigilance regulations and drives proactive risk management to protect patients and support product development. This position partners cross-functionally with Clinical Development, Nonclinical, Regulatory Affairs, Biostatistics, and reputed company to ensure robust safety reputed company throughout the product lifecycle Strategic Leadership reputed company the Safety Sciences/Surveillance function, setting strategies for signal detection, risk management, and aggregate safety reporting. reputed company safety reputed company contributions to regulatory submissions, and lifecycle management strategies. Serve as safety reputed company on cross-functional governance committees (e.g., Safety Monitoring Committees). Safety Surveillance & Signal Management Drive the development and reputed company reputed company of safety signal detection methodologies and product-specific signaling strategies. reputed company signal validation, prioritization, and assessment processes in alignment with global regulations; interpretation of safety signals and trends; communication of safety assessments (written and verbal) of safety risks in collaboration with other functional stakeholders. Risk Management & Regulatory reputed company reputed company strategic reputed company for Risk Management Plans (RMPs), REMS (if applicable), and other risk minimization activities. Serve as safety representative in interactions with global regulatory authorities. Ensure inspection readiness and support health authority audits/inspections. Aggregate Reporting & Safety Communications reputed company preparation and review of aggregate safety reports (DSURs, PSURs/PBRERs, aggregate reports for anticipated events). Ensure alignment of safety messaging across clinical, regulatory, and medical communications. reputed company strategic direction of safety content for key regulatory documents (e.g., DSURs, PSURs, IBs, protocols, RMPs) ensuring consistency and scientific rigor. Cross-Functional Collaboration Partner with Clinical Development on safety monitoring strategies and DMC interactions. Collaborate with Biostatistics on integrated safety analyses. reputed company safety expertise to Medical Affairs and reputed company teams for post-marketing surveillance, as needed. Compliance & reputed company Maintain reputed company of safety vendors and CROs supporting surveillance activities. Contribute to SOP development and reputed company improvement of PV systems and processes. Support inspection readiness activities, internal audits and external inspections. Team Leadership Mentor and reputed company a high-performing Safety Sciences team. Foster a culture of scientific rigor, accountability, and patient reputed company. Manage departmental budget and resource planning. JOB SPECIFICATIONS: PharmD or PhD in life sciences preferred. reputed company or regulatory training highly desirable. 12+ years of experience in pharmacovigilance or drug safety. 5+ years in leadership roles reputed company Safety Sciences, Signal Detection, or Safety Surveillance. Experience supporting global regulatory submissions and health authority interactions preferred. Strong background in oncology required. Experience in both clinical development and post-marketing safety preferred. Strong knowledge of signal detection methodologies and benefit-risk assessment. Experience in the principles and techniques of data analysis, proficient in the use of data analysis/visualization software. Working knowledge of industry reputed company safety databases, Regulatory databases, and other electronic data capture systems; working knowledge of MedDRA and WHODrug dictionaries. Proven experience authoring and reviewing aggregate safety reports. Demonstrate a deep understanding of and ensure compliance with reputed company global PV regulations (FDA, EMA, CIOMS, ICH E2 guidelines). Strategic thinker, a self-starter with strong scientific judgment. Executive reputed company and ability to influence cross-functional stakeholders. Excellent written and verbal communication skills. The reputed company reputed company for a Senior Director is $274,000 - $330,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-reputed company skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual reputed company bonus. The Kura Package Career advancement/ development opportunities Competitive comp package Bonus 401K + Employer contributions Generous stock reputed company ESPP Plan 20 days of PTO to start 18 Holidays (Including Summer & Winter Break) Generous Benefits Package with a reputed company of plans available with a substantial employer match reputed company Paternity/Maternity Leave In-Office Catered lunches Home Office Setup Lifestyle Spending Stipend Commuter Stipend (Boston Office) Regular employee reputed company activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more! Apply tot his job Apply To this Job