Drug Safety Specialist (FSP) - Day Shift

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Join Us as a Safety Specialist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in patient safety. As a Safety Specialist, you'll perform day-to-day Pharmacovigilance (PV) activities within a highly regulated environment driven by strict timelines. Your responsibilities will include the collection, monitoring, assessment, evaluation, research, and tracking of safety information. You will coordinate and perform PV activities such as data entry, coding, assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. You will effectively collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors. You may assist in the preparation of departmental and project-specific procedures and processes, and prepare for and attend audits, kick-off, and investigator meetings.

What You’ll Do:
• 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 Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience in PV case processing, triage, and/or peer review is required (minimum of 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