What the Associate II, Pharmacovigilance does at WorldwideResponsible 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. Serves as Lead PV Associate on moderate to large sized studies that are moderate to complex in scope of work with moderate support from senior staff.What you will doAuthor Safety Management Plan for assigned studiesAttend and present at Investigator MeetingsReview incoming SAE data for completeness and accuracyPerform data entry in the Safety Database and/or complete applicable tracking of incoming safety informationPerform QC of SAEs processed by other PV AssociatesGenerate regulatory reports and perform safety submissions as neededWhat you will bring to the roleStrong understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirementsStrong understanding of computer technology, and management of relational database systems, including extraction of dataExcellent organizational skills and ability to handle multiple competing priorities within tight timelinesConsistently demonstrates commitment, dependability, cooperation, adaptability and flexibility in executing daily tasks and responsibilitiesYour experienceMinimum of 3 years of pharmacovigilance experience (pre-approval clinical trials)Bachelor's degree in science related field, nursing or equivalent combination of relevant education and experienceComputer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word)Excellent written and verbal communication skillsExcellent organization skills and attention to detailDemonstrated ability to handle multiple competing priorities while adhering to applicable timelinesAbility to work independently, prioritize work effectively and work successfully in matrix team environmentAbility 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