Worldwide Clinical Trials ยท 1 week ago
Senior Associate, Pharmacovigilance - US - Remote
United States
Full-time
Remote
Senior Level
5+ years expWorldwide Clinical Trials is a global, midsize CRO dedicated to improving lives through innovative drug development. The Senior Associate in Pharmacovigilance will be responsible for authoring safety management plans, reviewing safety data, generating regulatory reports, and maintaining compliance with safety regulations.
Health CarePharmaceutical
Responsibilities
Author Safety Management Plan for assigned studies
Attend internal and client meetings as appropriate
Attend 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
Prepare and submit periodic safety reports as needed
Maintain knowledge and understanding of safety related regulations and guidelines
Maintain basic understanding of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope
May assist with bid defences or other presentations
May mentor or train new PV staff
Perform other duties as assigned
Qualification
Required
Excellent understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements
Excellent 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
Ability to anticipate needs and follow through on all assigned tasks
Able to effectively receive and provide constructive feedback without becoming defensive
Makes sound decisions within the scope of responsibility. Focuses on solutions and problem resolution verses complaining or placing blame
Good understanding of computer technology, and management of relational database systems, including extraction of data
Bachelor's degree in a science-related field, or nursing, or equivalent
Minimum of 5 years 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
Ability to work independently, prioritize work effectively and work successfully in matrix team environment
Ability and willingness for potential limited travel (domestic and international) as needed (attend Investigator Meeting, project kick-off meeting and/or bid defense meeting)
Fluent in written and verbal English
Company
Worldwide Clinical Trials
Worldwide Clinical Trials is a global CRO that provides preclinical and Phase I-IV clinical development services to pharmaceutical industry.
1001-5000 employees
H1B Sponsorship
Worldwide Clinical Trials has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (5)
2022 (3)
2021 (2)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2023-08-07Acquired
Leadership Team
Robyn Greener
Associate Director, Project Management
Recent News
2025-12-18
EIN Presswire
2025-11-19
2025-09-22
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