Work Schedule

Environmental Conditions

Job Description

Essential  Functions

 Performs day-to-day PV activities. May participate in on-call duties for specific 
projects to ensure 24-hr coverage for intake of cases from investigative sites. 
 Reviews regulatory/pharmacovigilance publications and information sources to 
keep updated on current regulations, practices, procedures and proposals. 
Maintains medical understanding of applicable therapeutic area and disease 
states. 
 Reviews cases entered for quality, consistency and accuracy, including review of 
peer reports. 
 Prepares and maintains regulatory safety reports.

Qualifications: 
Education and Experience: 
Bachelor's degree or equivalent and relevant formal academic / vocational qualification 
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

Knowledge, Skills and Abilities: 
 Strong critical thinking and problem solving skills
 Good oral and written communication skills including paraphrasing skills 
 Good command of English and ability to translate information into local language where required 
 Computer literate with the ability to work within multiple databases 
 Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel) 
 Understanding of medical terminology 
 Understanding the importance of and compliance with procedural documents and regulations 
 Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
 Strong attention to detail 
 Ability to maintain a positive and professional demeanor in challenging circumstances 
 Ability to work effectively within a team to attain a shared goal