[Hiring] Senior Drug Safety Specialist @Thermo Fisher Scientific

Role Description

Join Us as a Senior Safety Specialist – Make an Impact at the Forefront of Innovation. 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 Senior Safety Specialist, you'll perform and may oversee day-to-day Pharmacovigilance (PV) activities within a highly regulated environment driven by strict timelines. Your responsibilities will include, but are not limited to, the collection, monitoring, assessment, evaluation, research, and tracking of safety information. You will effectively collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors.

• Works independently to perform 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.
• Operates in a lead capacity. Provides assistance in the development of program and departmental procedural documents. May prepare for and attend audits. Mentors less experienced staff.
• 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.
• Responsible for 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.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• Must have PV (Clinical Trial or Post-marketed) case processing experience of no less than 4 years. Familiar with Argus database.
• 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.

Requirements

• Thorough understanding of pathophysiology and the disease process.
• Strong knowledge of relevant therapeutic areas as required for processing AEs.
• Excellent critical thinking and problem solving skills with ability to evaluate and escalate appropriately.
• Proficient at complex clinical study administration including budget activities and forecasting.
• Excellent 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.
• Proficient in Microsoft Office products (including Outlook, Word, and Excel).
• Thorough understanding of the global regulatory requirements and 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 with exposure to electrical office equipment.
• 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.

Benefits

• When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence.
• You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Company Description

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.