Safety Specialist

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.

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