Work Schedule

Environmental Conditions

Job Description

Performs day-to-day Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Performs activities such as adverse event data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third party vendors.

A day in the Life:Performs day-to-day PVG 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. Maintain 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.

EducationBachelor's degree or equivalent and relevant formal academic / vocational qualification

ExperiencePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

Knowledge, Skills, AbilitiesStrong critical thinking and problem solving skillsGood oral and written communication skills including paraphrasing skillsGood command of English and ability to translate information into local language where requiredComputer literate with the ability to work within multiple databasesPrevious exposure to Microsoft Office packages (including Outlook, Word, and Excel)Understanding of medical terminologyUnderstanding the importance of and compliance with procedural documents and regulationsAbility to manage and prioritize a variety of tasks and meet strict deadlines with limited supervisionStrong attention to detailAbility to maintain a positive and professional demeanor in challenging circumstancesAbility to work effectively within a team to attain a shared goal