Work Schedule
Other
Environmental Conditions
Office
Job Description
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.
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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
Additional / Specific Knowledge, Skills, and/or Abilities:
• Good knowledge and experience of global pharmacovigilance requirements relating to literature surveillance