[Work From Home] Safety Spacialist In Pharmacovigilance

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[Work From Home] Safety Spacialist In Pharmacovigilance

About the Company

Our team of colleagues in clinical research services is at the forefront of bringing cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, powering our PPD® clinical research portfolio, is part of our leading global contract research organization (CRO).

Position Details

Position Name: Safety Specialist
Organization: Thermo Fisher Scientific
Location: Work From Home
Salary: CTC: 5.10 LPA

Qualifications

• B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences

Experience

• 1 to 2 Years

Key Responsibilities

• Perform day-to-day Pharmacovigilance (PV) activities within a highly regulated environment and driven by strict timelines.
• PV activities include collection, monitoring, assessment, evaluation, research, and tracking of safety information.
• Coordinate and perform PV activities such as data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities.
• Collaborate with project team members, client contacts, investigators, adverse event reporters, and third-party vendors.
• Assist in preparing departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings.

Essential Functions

• Perform day-to-day PV activities; may participate in on-call duties for specific projects to ensure 24-hour coverage for intake of cases from investigative sites.
• Review regulatory/pharmacovigilance publications and information sources to stay updated on current regulations, practices, procedures, and proposals.
• Maintain medical understanding of applicable therapeutic areas and disease states.
• Review cases entered for quality, consistency, and accuracy, including peer report reviews.
• Prepare and maintain regulatory safety reports.
• Assist with routine project implementation and coordination, including presentations at client/investigator meetings, and review of metrics and budget considerations.
• Mentor less experienced staff.

Education and Experience

Education Level	Experience
Bachelor’s degree	2+ years of relevant formal academic/vocational qualification
Equivalency	Education, training, and/or directly related experience

Knowledge, Skills, and Abilities

• 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.

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Application Information:

Interested candidates can apply through our official website. Join us in ensuring drug safety from the comfort of your home!

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