Job Description

　　Performs day-to-day Pharmacovigilance (PV) 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. Coordinates and

　　performs Pharmacovigilance activities such as 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. May assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings.

　　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.

　　Assists with routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations. Mentors less experienced staff.

　　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 2+ years).

　　In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

　　Knowledge, Skills and Abilities:

　　General understanding of pathophysiology and the disease process

　　Detailed knowledge of relevant therapeutic areas as required for processing AEs

　　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 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