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Safety Data Specialist
• 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.
Consultnetworx is a national staffing firm that provides consultants, temp to hire, and full time employees to small/medium/ large companies in the areas of Human Resources, IT, Pharmaceutical, Corporate Support, Sales and Finance.
The Consultnetworx team prides itself on its personal, innovative and hands-on approach to business, with a focus on creative sourcing and cultivating client relationships. We call it Xtreme Recruiting-- and it works! Our firm has excellent recruiting metrics to prove it: 93% of the positions we search for are effectively filled by our team, 98% of our consultants successfully COMPLETE their assignments and 95% of first-time clients become repeat customers.
Not fully satisfied with the so-called advanced sourcing capabilities of internet job boards and niche sites, our principals had a transformative idea ... to enhance Consultnetworx by building a vast personal network of professional contacts, one relationship at a time. We launched a sister company, Speednetworx, and started hosting unique and exciting live speed networking events. As the popularity of these events grew, so did Consultnetworx. Today, our business boasts an ever-growing network of highly-coveted, passive talent that our competition can not offer you.
Our recruiters are required to have both in-house and staffing agency experience. In this way, they can fully understand the need of our clients as well as our candidates, recognize the contrasts (and characteristics) of different corporate cultures and align companies and employees for a mutually beneficial fit.
Equal Employment Opportunity Disclaimer
Consultnetworx is an Equal Opportunity employer. We do not discriminate in hiring or employment based upon race, color, religion, national origin, age, sex, sexual orientation, disability, Vietnam era military service, or any other basis on which discrimination is prohibited by federal, state or local laws. No question on our application is intended to secure information to be used for such discrimination.
Posted date: 4 years ago
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