Senior Drug Safety Specialist – Day Shift
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Job Description
Senior Safety Specialist performing Pharmacovigilance activities for a leading life sciences company. Joining a global team ensuring operational excellence in patient safety and compliance.
Responsibilities:
- 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.
Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Must have PV (Clinical Trial or Post-marketed) case processing experience of no less than 4 years. Familiar with Argus database.
- 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)
Benefits:
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
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