Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 skillsGood 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 supervisionStrong 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