Safety Specialist - Centralized Literature Team

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a posi

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. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Discover Impactful Work:

As a Safety Specialist you will be responsible for performing day-to-day Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines: collection, monitoring, assessment, evaluation, research and tracking of safety information, data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborating with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third-party vendors. Assisting in the preparation of departmental and project-specific procedures and processes, preparing for and attending audits, kick-off and investigator meetings.  

A day in the Life:

• Performs day-to-day PVG 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. Maintain 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

Additional / Specific Job Responsibilities:

• Conducts assessment and peer review of literature abstracts/articles for adverse events, special situation events, signal-relevant and aggregate safety report-relevant safety information and analysis of similar events (AOSE) for both developmental and market-authorized products.

• Serves as the primary point of contact for low to medium complexity literature projects (e.g. medium complexity projects with 1 to 5 products, projects involving review for ICSRs, signal[1]relevant, aggregate safety report-relevant safety information and/or AOSE, and projects with moderate to high volume of citations).

• Ensures that assigned literature surveillance tasks are conducted in accordance with company policies and procedures, contractual agreements and applicable regulations.

• Participates in departmental initiatives.

• May prepare for and attend audits, inspections and bid defenses.

Education

• 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. Knowledge, Skills, Abilities

• General understanding of pathophysiology and the disease process 

• Detailed knowledge of relevant therapeutic areas as required for processing AEs 

• Good knowledge and experience of global pharmacovigilance requirements relating to literature surveillance

• 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 

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.