What the senior associate, pharmacovigilance does 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.independently serves as lead pv associate on large sized studies/programs that are moderate to complex in scope of work.what you will doauthor safety management plan for assigned studiesreview incoming sae data for completeness and accuracyperform data entry in the safety database and/or complete applicable tracking of incoming safety informationgenerate queries for missing or unclear information and follow-up with sites for resolutionperform qc of saes processed by other pv associatesgenerate regulatory reports and perform safety submissions as needed what you will bring to the roleexcellent understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirementsexcellent understanding of computer technology, and management of relational database systems, including extraction of datapositive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environmentexcellent 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 experiencebachelor's degree in a science-related field, or nursing, or equivalentminimum of 5 years of pharmacovigilance experience (pre-approval clinical trials)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 organizational 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