Safety Specialist
1 week ago
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. Coordinates and performs Pharmacovigilance activities such as 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. May assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings.
Essential Functions and Other Job Information:
Essential Functions
• 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 (, 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.
Job Complexity
Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
Job Knowledge
Developing professional expertise, applies company policies and procedures to
resolve a variety of issues.
Supervision Received
Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Exercises judgment within defined procedures and practices to determine appropriate action.
Business Relationships
Contacts are primarily internal to the company with infrequent external customer / vendor contact on routine matters. Builds productive internal / external working relationships.
Qualifications:
Education and Experience:
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).
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
• 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
Management Role:
No management responsibility
Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment
• Daily exposure to high pressure and intense concentration
• Daily interactions with clients/associates
• Long, varied hours on occasion
• Travel required on occasion domestic and/or international
Physical Requirements:
• Frequently stationary for 6-8 hours per day
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements
of the fingers, hands, and wrists
• Frequent mobility required
• Occasional crouching, stooping, bending and twisting of upper body and neck
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop
computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf
• Ability to communicate information and ideas so others will understand; with the ability to listen to
and understand information and ideas presented through spoken words and sentences
• Frequently interacts with others to obtain or relate information to diverse groups
• Works independently with little guidance or reliance on oral or written instructions and plans work
schedules to meet goals
• Requires multiple periods of intense concentration
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions
with little predictability as to the occurrence
• Ability to perform under stress and multi-task
• Regular and consistent attendance
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