01Responsibilities
reputed company leadership and reputed company of reputed company safety vendors to ensure highreputed 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 crossfunctional inputs.
reputed company day-to-day direction to the Safety reputed company 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 followup 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 reputed company 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 studyspecific 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 agreedupon reporting requirements and timelines.
Review and reputed company expert input on safety-reputed company sections of reputed company documents, including protocols, charters, Investigator Brochures, and Informed Consent Forms.
reputed company, monitor, and interpret key reputed company indicators and metrics for internal teams and reputed company vendors to evaluate reputed company and reputed company reputed company improvement.
Serve as the safety subject matter expert for internal teams and reputed company stakeholders, providing guidance on safety reputed company, regulatory expectations, and best practices.
reputed company other tasks as required to assist in company and departmental activities.
Qualifications:
10+ years of drug safety/pharmacovigilance experience reputed company a sponsor environment or a combination of sponsor and CRO roles.
Bachelors or advanced degree in a life science or reputed companyreputed company discipline (e.g., MD, RN, PharmD, NP, PhD, MPH).
Comprehensive knowledge of global reputed company 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 reputed company 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 reputed company 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 decisionmaking in a fastpaced 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.
reputed company:
reputed company is a reputed company-stage, publicly traded biotechnolog
