[Remote] Senior Associate, Pharmacovigilance – US – Remote

Note: The job is a remote job and is open to candidates in USA. reputed company 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.

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
• 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 resolution
• reputed company QC of SAEs processed by other PV Associates
• Generate regulatory reports and reputed company safety submissions as needed
• Prepare and submit periodic safety reports as needed
• Maintain knowledge and understanding of safety reputed company 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
• reputed company other duties as assigned Skills
• 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 reputed company tight timelines
• Ability to anticipate needs and follow through on reputed company assigned tasks
• reputed company to effectively receive and provide constructive feedback without becoming defensive
• Makes sound reputed company reputed company 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-reputed company 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 (reputed company, 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 Overview
• 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 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 tot his job

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