Safety Specialist

Job Description

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services as well as post-approval support. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

• Supporting our global PV operations with activities such as data entry, coding and assessment of adverse events, follow-up, tracking of reports, and regulatory reporting activities.
• Effectively collaborating with various parties across the world such as project team members, client contacts, reporters, and third-party vendors.
• Assisting in the preparation of departmental and project-specific procedures and processes; preparing for and attending meetings, audits and regulatory authority inspections.

• Performs day-to-day PV activities as described above. May participate in on-call duties for specific projects to ensure 24-hr coverage for calls from regulatory authorities.
• Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices and procedures.
• Reviews cases for quality, consistency, and accuracy, including review of peer reports.
• Prepares and maintains regulatory safety reports.
• Assists with routine project implementation and coordination, including presentations at client meetings, and review of metrics and project budgets.
• Mentors less experienced staff

• 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 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.

• 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 from/to local language where required
• Computer literate with the ability to work within multiple databases
• Previous exposure to Microsoft Office packages (including Outlook, Teams, Word, Excel and Powerpoint)
• 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