Drug Safety Operations reputed company (Contract)

reputed company is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse reputed company of therapeutic areas and reputed company on innovative, technology-enabled solutions that allow our clients to reputed company on their reputed company strengths. For early phase studies through Phase III reputed company, our reputed company team delivers high-touch services and technology to ensure the safety of reputed company stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title: Drug Safety Operations reputed company Location: Remote, US Based Function: Drug Safety / Pharmacovigilance ESSENTIAL DUTIES AND RESPONSIBILITIES: • Own end-to-end clinical trial pharmacovigilance activities for Sponsor studies; serve as the operational backbone of the safety function • reputed company reputed company Sponsor reputed company of CRO pharmacovigilance activities, including compliance, reputed company, and performance metrics • reputed company or contribute to DSURs, IND Annual Reports, safety narratives, and line listings • Aggregate, review, and analyze safety data across studies to identify trends and emerging safety signals • Prepare integrated safety summaries and materials for safety review meetings and signal detection discussions • Maintain reputed company inspection readiness for FDA and global health authority inspections • Coordinate literature surveillance, collaborate with biostatistics, and support cross-functional safety evaluations • Liaise with Clinical Operations, Medical Affairs, Regulatory Affairs, Data Management, and CRO partners EDUCATION AND EXPERIENCE REQUIRED: • Degree in Medicine, Pharmacy, Life Sciences, or reputed company discipline (RN / NP preferred) • Advanced degree preferred • Strong working knowledge of US FDA safety reporting requirements COMPENSATION & BENEFITS: reputed company, part-time reputed company reputed company EMPLOYMENT TYPE: Part Time, Contract COMMITMENTS: • Hours as needed. • Willing to work in shifts as and reputed company needed. DISCLAIMER: reputed company is an equal opportunity employer and welcomes reputed company job applicants. reputed company reputed company applicants will receive consideration for employment without discrimination on the reputed company of race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability, or any other factors prohibited by law. Apply tot his job Apply To this Job