[Remote] Associate II, Pharmacovigilance - US - Remote

Note: The job is a remote job and is open to candidates in USA. Worldwide Clinical Trials 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 quality control, and generating regulatory reports to ensure drug safety throughout clinical trials. Responsibilities • Author Safety Management Plan for assigned studies • Attend internal and client meetings as appropriate and present at Investigator Meetings • Review incoming SAE data for completeness and accuracy • Perform 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 resolution • Perform QC of SAEs processed by other PV Associates • Generate regulatory reports and perform 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 • Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment • Excellent organization skills and ability to handle multiple competing priorities within tight timelines • Consistently demonstrates commitment, dependability, cooperation, adaptability and flexibility in executing daily tasks and responsibilities • Able to effectively receive and provide constructive feedback without becoming defensive • Able to work well independently, but also able to seek input effectively from others when appropriate. Makes sound decisions within the scope of responsibility. Focuses on solutions and problem resolution verses complaining or placing blame • Minimum of 1 year of pharmacovigilance experience (pre-approval clinical trials) • Equivalent combination of relevant education and experience • Computer literacy and strong working knowledge of MS Office applications (Excel, 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 matrix team environment Education Requirements • Bachelor’s degree in a science-related field, nursing, or equivalent Company Overview • Worldwide Clinical Trials 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, North Carolina, USA, with a workforce of 1001-5000 employees. Its website is https://www.worldwide.com. Company H1B Sponsorship • Worldwide Clinical Trials has a track 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 To this Job Apply tot his job Apply To this Job