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Associate Drug Safety Specialist (Night Shift)
Lensa
United States
Remote
USD 50,000 - 75,000
Full time
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Job summary
A leading company is seeking an Associate Drug Safety Specialist for remote work. The role involves conducting daily pharmacovigilance activities to ensure compliance with regulations and safety in drug development. Ideal candidates will hold a bachelor's degree and possess problem-solving skills, as well as the ability to work collaboratively in a fast-paced environment.
Qualifications
- Degree in relevant field with at least 0-2 years of experience.
- Strong communication skills and ability to work in a team.
- Experience with regulatory compliance and medical terminology.
Responsibilities
- Perform day-to-day Pharmacovigilance (PVG) activities.
- Ensure adherence to regulatory standards and reporting.
- Collaborate with project team members and external parties.
Skills
Education
Tools
Job description
Thermo Fisher Scientific
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Performs day-to-day Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Performs activities such as adverse event data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third party vendors.
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.
Education
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Experience
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
Knowledge, Skills, 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
Computer literate with the ability to work within multiple databases
Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel)
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
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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Associate Drug Safety Specialist (Night Shift)
Thermo Fisher Scientific • Remote
Work Schedule Environmental Conditions Job Description Performs day-to-day Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation,...
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