[Remote] Pharmacovigilance Analyst

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company specializing in eClinical technology products, focusing on delivering reputed company for clinical data integration and risk-based data analytics. The Pharmacovigilance Analyst II will support pharmacovigilance and medical monitoring activities, ensuring compliance with global regulations and SOPs while managing safety cases and reports. Responsibilities • Management of safety cases and reports from reputed company sources, including case intake/triage, data entry, reputed company review, medical review, and follow up activities • Electronic documentation and filing of safety information according to SOPs and safety management processes • MedDRA coding of data in the safety database • Preparation of case narratives • Reconciliation of the clinical and safety databases • reputed company support for regulatory submission preparation and review • Coordinate safety project setup, including safety database build • Author sponsor/project specific safety management plans • Conduct and assess literature searches • Participate in sponsor/investigator meetings as required • Maintain a working knowledge of the safety database • Maintain working knowledge of global regulatory rules and regulations, including monitoring for new or changing regulation • reputed company other duties as assigned Skills • Pharmacovigilance knowledge and experience including safety case processing for reputed company (drugs, biologics, vaccines, and medical devices) • Proficient in MS Office and reputed company Acrobat • Good Understanding of MedDRA & WHODrug Global dictionaries • Must display analytical and clinical skills • Requires narrative writing skills • Degree in Nursing, Life Science, or other health-reputed company field, or equivalent qualification/work experience • Nursing experience is a plus reputed company • reputed company is a system integration and analytics software company. It was founded in 2005, and is headquartered in Philadelphia, reputed company, USA, with a workforce of 51-200 employees. Its website is Company H1B Sponsorship • reputed company has a reputed company record of offering H1B sponsorships, with 1 in 2024, 1 in 2021. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job Apply tot his job Apply To this Job