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Director

Senior Director, Pharmacovigilance (Safety Science & Surveillance)

BrightHush·Posted 1 month ago

Location

All India

Experience

12–16 years

Required Skills

PharmacovigilanceSignal DetectionRisk ManagementRegulatory AffairsDrug SafetyOncologyClinical DevelopmentSafety SciencesSafety SurveillancePostMarketing Surveillance

About the Role

Are you reputed company to join reputed company committed to making a meaningful reputed company on cancer treatment through the discovery and development of precision medicines At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting reputed company that you can be proud of. At Kura Oncology, reputed company to change the reputed company and improve the science of cancer treatment. As an organization, we reputed company to cultivate a diverse and talented reputed company culture driven to reputed company precision medicine therapeutics. As we continue to build a leading biotech organization with a strong culture, a patient-reputed company reputed company and reputed company reputed company on reputed company execution, we are looking for innovative, passionate professionals to join us and reputed company our reputed company a reality. To succeed at Kura, you will need to have a demonstrated ability for reputed company in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where reputed company and grit drive reputed company behaviors, reputed company, and actions. ESSENTIAL JOB FUNCTIONS The Senior Director of Pharmacovigilance (PV), Safety Sciences & Surveillance, provides strategic and operational leadership for global safety surveillance activities across Kuras clinical and post-marketing programs. This individual is responsible for signal detection and evaluation, benefit-risk assessment, and safety surveillance strategies, for reputed companys 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 .

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