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 Worldwide Clinical Trials, 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 believe 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 all 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 thrive by being themselves and are inspired to do their best work every day. Join us!
What the Senior Associate, Pharmacovigilance does Worldwide
Responsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable regulatory guidelines/requirements, Worldwide Standard Operating Procedures (SOPs) and project specific instructions. Independently serves as Lead PV Associate on large sized studies/programs that are moderate to complex in scope of work.
What you will do
Author Safety Management Plan for assigned studies
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
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 organizational 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
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
Excellent organizational 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
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 better life because of the work we do.
To view our other roles, check 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 LinkedIn.
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’re 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.
Worldwide Clinical Trials is a global, midsize Contract Research Organization (CRO) that specializes in clinical trial management and execution for pharmaceutical and biotech sponsors. With over 3,500 experts, the company pushes boundaries through pioneering, creative approaches to clinical research while maintaining quality and excellence. Their mission is to work with passion and purpose to improve lives by helping bring cures to the world's most persistent diseases. The company provides comprehensive clinical trial services including clinical site management, investigator grants forecasting, and proposal development, serving as a critical partner in advancing breakthrough scientific research for patients and caregivers.
