Sr Safety Specialist

Work Schedule

Environmental Conditions

Job Description

Summarized Purpose:

Performs and may oversee day-to-day Pharmacovigilance (PV) 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.  Effectively collaborates with various parties such as: project team members, client contacts, investigators,  and adverse event/ reporters, and third party vendors.

Essential  Functions

• Works independently to perform day-to-day PV activities. May participate in on call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.
• Operates in a lead capacity. Provides assistance in the development of program and departmental procedural documents. May prepare for and attend audits. Mentors less experienced staff.
• Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states.
• Reviews cases entered for quality, consistency and accuracy, including review of peer reports.
• Responsible for 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.

Qualifications:

Education and Experience:

• Must be Life Science or Clinical Science Graduate or Post Graduate
• Should have 3+ years of experience in Case Processing related activities

Knowledge, Skills and Abilities:

• Thorough understanding of pathophysiology and the disease process
• Strong knowledge of relevant therapeutic areas as required for processing AEs
• Excellent critical thinking and problem solving skills with ability to evaluate and escalate appropriately
• Proficient at complex clinical study administration including budget activities and forecasting
• Excellent 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
• Proficient in Microsoft Office products (including Outlook, Word, and Excel)

• Thorough understanding of the global regulatory requirements and 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