Associate II, Pharmacovigilance
Multiple Locations: Mexico • Brazil
Requisition Number: 7550
Position Title: Associate II, Pharmacovigilance
Who we are
Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
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 you will do
- Author Safety Management Plan for assigned studies. Attend internal and client meetings as appropriate and present at Investigator Meetings
- Review incoming SAE data for completeness and accuracy. Perform QC of SAEs processed by other PV Associates
- 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. Generate regulatory reports and perform safety submissions as needed. Prepare and submit periodic safety reports as needed
What you will bring to the role
- Good understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements
- Good 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
- Bachelor’s degree in a science-related field, nursing, or equivalent
- Minimum of 3 years of pharmacovigilance experience (pre-approval clinical trials)
- Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word)
- Excellent written and verbal communication skills
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 www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
Employment Type: Regular
Community / Marketing Title: Associate II, Pharmacovigilance
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.