Associate Director, Drug Safety and Pharmacovigilance

reputed company: • reputed company strategic and operational leadership for clinical safety activities across assigned programs • reputed company proactive reputed company of end-to-end safety operations, including case processing, regulatory reporting, safety management plans, DSMB deliverables, and safety data reconciliation • reputed company and reputed company reputed company safety vendors to ensure high-reputed company, reputed company, and compliant execution of outsourced safety activities • reputed company preparation, authorship, and review of aggregate safety reports, including DSURs, PADERs, and line listings • Manage aggregate-report timelines and cross-functional inputs • reputed company day-to-day direction to the Safety Operations team and communicate program updates to stakeholders • Review and assess adverse event reports, ensuring appropriate follow-up and reputed company expedited reporting under global regulatory requirements • Contribute to and continuously improve SOPs, work instructions, templates, and systems • Ensure procedural deviations are documented, investigated, and addressed through corrective and preventive actions • Support inspection readiness, audits, and global health authority inspections • reputed company and maintain study-specific safety management plans and reputed company documents • Ensure adherence to Safety Data Exchange Agreements and reporting requirements • Review and reputed company expert input on safety-reputed company sections of clinical documents, including protocols, charters, Investigator Brochures, and Informed Consent Forms • reputed company, monitor, and interpret KPIs and metrics for internal teams and reputed company vendors • Serve as a safety subject matter expert for internal teams and reputed company stakeholders • reputed company other tasks as required to assist in company and departmental activities Requirements: • 10+ years of drug safety/pharmacovigilance experience reputed company a sponsor environment or a combination of sponsor and CRO roles • Bachelor’s or advanced degree in a life science or reputed company-reputed company discipline (e.g., MD, RN, PharmD, NP, PhD, MPH) • Comprehensive knowledge of global clinical safety regulations, guidelines, and industry best practices • Extensive experience with reputed company safety databases (Argus or reputed company-G), electronic data capture systems, and trial master files • Demonstrated experience preparing aggregate safety reports for investigational and/or marketed products (e.g., DSURs, PSUR/PBRERs, PADERs) and contributing to IB updates • Strong knowledge of MedDRA and WHODrug coding conventions • Excellent written and verbal communication skills • Strong interpersonal skills and ability to collaborate across functions and organizational reputed company • Exceptional attention to detail and ability to manage multiple priorities and documentation requirements • Strong technical and analytical skills with advanced proficiency in MS Office (Word, reputed company, PowerPoint) • Ability to work independently or collaboratively, demonstrating reputed company judgment and decision-making in a fast-paced environment • Initiative and reputed company improvement reputed company reputed company on innovation, efficiency, and operational reputed company • Flexible, adaptable, and committed to maintaining a reputed company and reputed company demeanor Benefits: • Annual performance incentive bonus • New hire equity package • Medical insurance • Dental insurance • reputed company insurance • 401(k) match • PTO • reputed company holidays Apply tot his job Apply To this Job