Drug Safety Specialist (Level I, II or III)

Thermo Fisher Scientific • Full-time • Remote (Massachusetts, United States, US) • 3d ago

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 – To enable 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. As part of our clinical research portfolio, our CorEvitas evidence-based solutions specialize in generating data intelligence and clinical insights needed to bring safe and effective treatments to market. Your objectivity and dedication to patient safety will improve health outcomes that people and communities depend on – now and in the future.

Location/Division Specific Information

Remote/Pharmacovigilance

#CorEvitas

Discover Impactful Work:

Quality and accuracy of reporting Drug Safety events is a critical function within CorEvitas, part of Thermo Fisher Scientific. This role will support the collection, tracking, data management, adjudication and reporting of adverse events reported by registry sites to support post authorization safety study analysis and other safety reporting commitments. Quality Control (QC) of the data will be achieved in accordance with Company SOP’s, and relevant regulatory standards.

A day in the Life:

Support timely and accurate Drug Safety reporting for critical daily functions including: AE surveillance, intake, triage, ICSR drafting and submission, QC of reported cases while ensuring adherence to department safety reporting plans and SOPs.
Demonstrate working familiarity with SOPs, work instructions and key references applicable to CorEvitas’s Drug Safety operations (e.g. site manuals, questionnaires, report plans, templates)
Demonstrate proficiency with standard tools and software systems (and their intended functionality) used to support core Drug Safety functions and reporting deliverables for a variety of end users.
Support QC investigations and regular site follow-up activities/cycles on missing or disparate Drug Safety reports, supporting documentation and critical data elements.
Provide support for Drug Safety data migration planning, implementation activities, as assigned and participate in departmental strategic planning, problem solving, and quality improvement initiatives.
Support preparation and delivery of queued cases to assigned adjudication teams.
Complete standard quality checks and to ensure accuracy and consistency in reporting across registries, and for client deliverables as applicable.
Provide processing support for a range of contracted, safety-related deliverables (e.g. individual case safety reports, adverse event listings, QC and reconciliation reporting).
Support capacity-building objectives by providing detailed feedback and mentoring to more junior team members, where appropriate, and in accordance with internal policies and procedures.
Coordinate/participate in workgroup meetings and follow-up activities for assigned deliverables, as appropriate.
Participate in departmental strategic planning, problem solving, and quality improvement initiatives.
Demonstrate familiarity with relevant governing regulations and guidance applicable to CorEvitas’ observational research model and drug safety surveillance and reporting obligations, specifically.
Develop risk-based approaches and QA strategies across registries, deliverables, and commitments.
Support technology and software solutions for daily integration into daily operations.
Ensure training documentation are complete and up to date for all roles.
Function as a PV lead/representative for assigned projects, workgroups and/or conference calls.
Other duties as assigned (temporary or permanent, based on company needs).

Keys to Success:

Education

Bachelors of Science (Master’s preferred);
Clinical background preferred.

Experience

Must have at least 2 years of relevant clinical research and/or Drug Safety experience.
Completion of GCP, MedDRA, and other role-specific training programs, as assigned.

Knowledge, Skills, Abilities

Must be highly organized and detail-oriented, with excellent time management skills.
Strong written and verbal communication skills.
Demonstrate advanced skills in core competency areas relevant to PV and safety data management
Proficiency in MS Office: Word, PowerPoint, Excel, Access, and MS Project.
Ability to work independently or part of a team.

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 Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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.

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