Safety Specialist

Thermo Fisher Scientific; United States; Remote; USD 70,000 - 90,000; Full time

Job summary

A leading company in the life sciences industry seeks a Pharmacovigilance specialist to perform day-to-day PV activities within a regulated environment. The role involves collecting and evaluating safety information, managing regulatory reports, and collaborating with various stakeholders. Ideal candidates will have 4+ years of experience in pharmacovigilance and a solid understanding of clinical processes and regulatory standards.

Qualifications

• Min 4+ years of experience in PV case processing.
• Experience in Clinical Trials and PMS cases.
• Good command of English and ability to translate information.

Responsibilities

• Performs day-to-day pharmacovigilance activities.
• Reviews cases for quality, consistency, and accuracy.
• Prepares and maintains regulatory safety reports.

Skills

Critical thinking

Problem solving

Communication

Attention to detail

Education

Bachelor's degree or equivalent

Tools

Argus Database

Microsoft Office

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summarized Purpose:

Performs day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environmentand driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinates andperforms Pharmacovigilance activities such as data entry, coding and assessment of adverse events, casereview, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborates withvarious parties such as: project team members, client contacts, investigators, and adverse event/reporters, and third party vendors. May assist in the preparation of departmental and project-specificprocedures and processes, prepare for and attend audits, kick-off and investigator meetings.

EssentialFunctions:

• Performs day-to-day PV activities. May participate in on-call duties for specificprojects to ensure 24-hr coverage for intake of cases from investigative sites.
• Reviews regulatory/pharmacovigilance publications and information sources tokeep updated on current regulations, practices, procedures and proposals.Maintains medical understanding of applicable therapeutic area and diseasestates.
• Reviews cases entered for quality, consistency and accuracy, including review ofpeer 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), includingpresentations at client/investigator meetings, and review of metrics and budgetconsiderations. Mentors less experienced staff

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Knowledge, Skills and Abilities:

• Min 4+ Years of expereince in PV case processing
• Should have worked in Clinical Trial and PMS cases
• Should have working expereince in Argus Database
• General understanding of pathophysiology and the disease process
• Detailed knowledge of relevant therapeutic areas as required for processing AEs
• 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