Job Description

Senior Associate, Pharmacovigilance - US - Remote Join to apply for the Senior Associate, Pharmacovigilance - US - Remote role at Worldwide Clinical Trials . About Worldwide Clinical Trials Worldwide Clinical Trials is a global, midsize CRO dedicated to pushing boundaries and innovating to develop cures for persistent diseases. We prioritize diverse, inclusive collaboration and rely on quality and excellence in delivering life‑changing products. What the role does Pharmacovigilance ensures drug safety through reviewing safety events worldwide and collaborating with clients to analyze, submit, and report data to investigators, ethics committees, IRBs, and regulatory agencies. The team supports the entire lifecycle of a compound from first‑in‑human administration to global regulatory approval. What You Will Do 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 What You Will Bring To The Role 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 Your Experience 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 Job Details Seniority level: Mid‑Senior level Employment type: Full‑time Job function: Research, Analyst, and Information Technology Industries: Research Services Equal Opportunity Statement Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We are on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. #J-18808-Ljbffr Worldwide Clinical Trials

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