Safety Specialist

As a Safety Specialist, you will be responsible for performing daily PV activities within a regulated environment, including:

• Monitoring, collecting, translating, disseminating, and tracking safety information
• Serving as a regulatory authority contact point
• Supporting global PV operations with data entry, coding, adverse event assessment, follow-up, tracking reports, and regulatory reporting activities
• Collaborating with project team members, client contacts, reporters, and third-party vendors
• Assisting in preparing departmental and project-specific procedures and processes
• Preparing for and attending meetings, audits, and regulatory authority inspections

This role offers an opportunity to advance your PV career while gaining exposure to both post-approval and clinical trial settings.

A Day in the Life

• Perform daily PV activities
• Participate in on-call duties for 24-hour coverage for regulatory authority calls
• Review regulatory/pharmacovigilance publications and information sources to stay updated on current regulations, practices, and procedures
• Review cases for quality, consistency, and accuracy
• Prepare and maintain regulatory safety reports
• Assist with routine project implementation and coordination, including presentations at client meetings and review of metrics and project budgets
• Mentor less experienced staff

Education

• bachelors degree or equivalent formal academic/vocational qualification
• Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
• In some cases, a combination of education, training, and/or directly related experience will be considered sufficient

Knowledge, Skills, Abilities

• Strong critical thinking and problem-solving skills
• Good oral and written communication skills, including paraphrasing
• Good command of English and ability to translate information to/from the local language
• Computer literate with the ability to work within multiple databases
• Previous exposure to Microsoft Office packages (Outlook, Teams, Word, Excel, PowerPoint)
• Understanding the importance of and compliance with procedural documents and regulations
• Ability to manage and prioritize 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 achieve a shared goal