Associate Safety Specialist

About the Role

As an Associate Safety Specialist at Thermo Fisher Scientific, you will perform day-to-day Pharmacovigilance (PV) activities within a highly regulated environment driven by strict timelines. You will ensure operational excellence that makes a real difference in patient safety, supporting top pharmaceutical companies and biotechs.

Key Responsibilities

• Perform day-to-day Pharmacovigilance (PV) activities.
• May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.
• Review 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.
• Review cases for quality, consistency, and accuracy, including review of peer reports.
• Prepare and maintain regulatory safety reports.
• Collect, monitor, assess, evaluate, research, and track safety information.
• Perform activities such as adverse event data entry, coding, assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities.
• Effectively collaborate with project team members, client contacts, investigators, adverse event reporters, and third-party vendors.

Requirements & Tech Stack

• Computer literate with the ability to work within multiple databases.
• Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel).

Qualifications

• 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).
• In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered sufficient.

Skills and Abilities

• 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.
• 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.

Working Conditions and Environment

• Work is performed in an office environment.
• Daily exposure to high pressure and intense concentration.
• Daily interactions with clients/associates.
• Long, varied hours on occasion.
• Travel required on occasion (domestic and/or international).