FSP – Associate Safety Specialist

Overview

Perform day-to-day Pharmacovigilance (PV) activities within a highly regulated environment driven by strict timelines, supporting patient safety through the collection, monitoring, assessment, evaluation, research and tracking of safety information.

What you'll do

• Perform day-to-day PV activities, including adverse event data entry, coding, assessment of adverse events, case review, follow-up, tracking of reports and regulatory reporting activities.
• May participate in on-call duties for specific projects to ensure 24-hour coverage for intake of cases from investigative sites.
• Review regulatory and pharmacovigilance publications and information sources to stay current on regulations, practices, procedures and proposals.
• Maintain medical understanding of the applicable therapeutic area and disease states.
• Review entered cases for quality, consistency and accuracy, including review of peer reports.
• Prepare and maintain regulatory safety reports.
• Collaborate with project team members, client contacts, investigators, adverse event reporters and third-party vendors.

What you'll need

• 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); an equivalency of appropriate education, training and/or directly related experience may be considered.
• 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.

Details

• Work schedule: standard Monday to Friday.
• Work is performed in an office environment with exposure to electrical office equipment.
• Daily exposure to high pressure and intense concentration; daily interactions with clients and associates.
• Long, varied hours on occasion.
• Travel required on occasion, domestic and/or international.