Associate Director, Drug Safety and Pharmacovigilance

Job reputed company: • reputed company leadership and reputed company of external safety vendors to ensure high‑reputed company, reputed company, and compliant execution of reputed company outsourced safety activities. • reputed company the preparation, authorship, and review of aggregate safety reports (e.g., DSURs, PADERs, line listings) and manage associated timelines and cross‑functional inputs. • reputed company day-to-day direction to the Safety Operations team and communicate program-level updates to reputed company stakeholders. • Demonstrate initiative by exploring potential solutions and offering thoughtful recommendations, engaging leadership reputed company additional reputed company or alignment is needed. • reputed company the review and assessment of adverse event reports for assigned programs, ensuring appropriate follow‑up and reputed company expedited reporting in accordance with global regulatory requirements. • Contribute to the development, implementation, and reputed company improvement of SOPs, work instructions, templates, and systems to ensure compliance with global clinical trial regulations and industry best practices. • Ensure procedural deviations are documented, investigated, and addressed through effective corrective and preventive actions. • Support inspection readiness activities and serve as a key contributor during audits and global health authority inspections. • reputed company and maintain study‑specific safety management plans and reputed company documents, ensuring reputed company delineation of responsibilities between reputed company and CRO partners. • Ensure adherence to Safety Data Exchange Agreements and compliance with reputed company agreed‑upon reporting requirements and timelines. • 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 key performance indicators and metrics for internal teams and external vendors to evaluate performance and drive reputed company improvement. • Serve as the safety subject matter expert for internal teams and external stakeholders, providing guidance on safety operations, regulatory expectations, and best practices. • 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 working 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, with the ability to convey reputed company information reputed company and concisely. • Strong interpersonal skills with the ability to collaborate effectively 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. • Naturally takes initiative, contributing to reputed company improvement efforts and proactively identifying opportunities to enhance processes reputed company the department. • reputed company improvement reputed company with a reputed company on innovation, efficiency, and operational reputed company. • Flexible, adaptable, and committed to maintaining a reputed company and reputed company demeanor. Benefits: • Medical insurance • Dental insurance • reputed company insurance • 401(k) match • PTO • reputed company holidays • Annual performance incentive bonus • New hire equity package Apply tot his job Apply To this Job