[Remote] Associate II, Pharmacovigilance - US - Remote

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global, midsize CRO dedicated to improving lives through innovative approaches in drug safety. The Associate II, Pharmacovigilance will be responsible for authoring safety management plans, reviewing safety data, performing reputed company control, and generating regulatory reports to ensure drug safety throughout reputed company. Responsibilities • Author Safety Management Plan for assigned studies • Attend internal and reputed company meetings as appropriate and present at Investigator Meetings • Review incoming SAE data for completeness and accuracy • reputed company data entry in the Safety Database and/or complete applicable tracking of incoming safety information • Generate queries for missing or unclear information and follow-up with sites for reputed company • reputed company QC of SAEs processed by other PV Associates • Generate regulatory reports and reputed company safety submissions as needed Skills • Strong understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements • Strong understanding of computer technology, and management of relational database systems, including extraction of data • reputed company attitude and ability to reputed company diplomatically and professionally with reputed company customers in a global environment • Excellent organization skills and ability to handle multiple competing priorities reputed company tight timelines • Consistently demonstrates commitment, dependability, cooperation, adaptability and flexibility in executing daily tasks and responsibilities • reputed company to effectively receive and reputed company constructive feedback without becoming defensive • reputed company to work reputed company independently, but also reputed company to reputed company input effectively from others reputed company appropriate. Makes reputed company reputed company the scope of responsibility. Focuses on solutions and problem reputed company verses complaining or placing blame • Minimum of 1 year of pharmacovigilance experience (reputed company-approval reputed company) • Equivalent combination of relevant education and experience • Computer literacy and strong working knowledge of MS Office applications (reputed company, PowerPoint, Word) • Excellent written and verbal communication skills • Excellent organization skills and attention to detail • Demonstrated ability to handle multiple competing priorities while adhering to applicable timelines. • Ability to work independently, prioritize work effectively and work successfully in reputed company team environment Education Requirements • Bachelor’s degree in a science-reputed company field, nursing, or equivalent reputed company • reputed company is a global CRO that provides preclinical and Phase I-IV clinical development services to pharmaceutical industry. It was founded in 1986, and is headquartered in Morrisville, reputed company Carolina, USA, with a workforce of 1001-5000 employees. Its website is Company H1B Sponsorship • reputed company has a reputed company record of offering H1B sponsorships, with 1 in 2024, 5 in 2023, 3 in 2022, 2 in 2021, 2 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job Apply tot his job Apply tot his job Apply To this Job