Our client, a fast paced, growing pharmaceutical company in Central NJ is seeking a Safety Data Specialist, for about 6 months. This position pays up to $47/hour, depending upon experience.
• Responsible for collection and processing of spontaneous and clinical trial adverse event and pregnancy reports, which includes data entry and verification of information into the safety database.
• Responsible for medical evaluation of relevant reports, which includes narrative generation, causality assessment, and event coding in the safety database.
• Generate and issue follow-up queries (clinical trial reports) and follow-up letters (spontaneous reports) to reporters.
• Responsible for telephone and written communication with physicians, other healthcare professionals (HCPs), company sales personnel and clinical research associates, and consumers in response to spontaneous and clinical trial Adverse Drug Reactions, Medical Devices Experiences, and technical reports associated with products.
• Responsible for triage of adverse event (AE) and malfunction reports according to Standard Operating Procedures (SOP), Global Safety (GS) Agreements and with respect to Food and Drug Administration (FDA) reporting guidelines.
• Responsible to maintain compliance with internal (GS) and external (FDA) reporting timelines.
• Responsible for conducting investigations into adverse drug and device reports for products with respect to applicable Federal regulations (IND, NDA, MDR, GMP) and internal SOPs.
• Assist product safety (PS) management with training of personnel on all job-related tasks.
• Assist PS management with communication to other departments within the company and globally concerning adverse event reports.
• Manage and support relationships with other key stakeholders (i.e. GS, Clinical Trial Management, Medical Affairs, and Regulatory Affairs).
• Maintain high state of knowledge of AE regulations, guidelines and standards related to pharmacovigilance, safety surveillance and regulatory reporting requirements.
• Maintain strong working knowledge of PS database systems: GCC (Global Customer Complaints) and ARGUS.
• Assist manager(s) with preparation of periodic and annual reports as needed.
• Assist with Clinical Trial reconciliation if applicable.
• Assist with department related projects as needed.
• Drive process improvement initiatives as needed.
• Bachelor of Science in health or life sciences required. Registered Nurse, Pharmacist, other health care professional, or advanced degree preferred.
• At least two years of prior experience required, specifically in product safety, pharmacy practice, or clinical practice.
• Exceptional knowledge of medical terminology and MedDRA coding.
• Intermediate proficiency required in Windows, Microsoft Word, and Excel.
• Strong oral and written communication skills preferred.
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