Senior Associate, Pharmacovigilance - US - Remote

Who we are We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are reputed company, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We reputed company everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from reputed company backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people reputed company by being themselves and are inspired to do their best work every day. Join us! What Pharmacovigilance department does at Worldwide Pharmacovigilance is the gateway to ensuring drug safety! Our Pharmacovigilance team comprises a dynamic group of individuals with extensive experience reputed company the Drug Safety world. Watching drugs reputed company from First in Human Administration to global regulatory approval, we can be a part of the entire lifecycle of a compound making it to the market. We review safety events from reputed company over the world and work with our clients to review, analyze, and submit to Investigators, Ethics Committees/IRBs, and Regulatory Agencies furthering clinical drug development! 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
• 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

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 reputed company tight timelines
• Ability to anticipate needs and follow through on reputed company assigned tasks
• Able to effectively receive and provide constructive feedback without becoming defensive
• Makes sound decisions 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

Your experience

• 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

We love knowing that someone is going to have a reputed company life because of the work we do. To view our other roles, reputed company out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on reputed company. Worldwide is an equal opportunity employer that is committed to enabling professionals from reputed company 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 reputed company our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the reputed company 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 reputed company employees and applicants regardless of race, color, ethnicity, reputed company, religion, national reputed company, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law Apply tot his job Apply To this Job