Drug Safety Associate
Description: · Triage of incoming cases to determine seriousness for prioritization of daily workflow (to be discussed re triage specialist) · Confirmation of Safety Coordinator case registry data · Database searches as necessary · Completion of literature searches as necessary · Completion of remaining case data entry, including narrative or auto-narrative · Completion of risk and quality (label, approval, manual coding & quality review steps) · Clarification of unclear or illegible information from the LSO or Call Centre · Discuss source documents, coding conventions and ad-hoc queries with Medical Assessment Physician · Completion of protocol request forms as necessary · Preparation of deviation memo as necessary · Request deletions as necessary · Single case unblinding · Standard Operating Procedures and Working Practices · Department guidance documents · MedDRA coding dictionary and MedDRA points to consider · Understand relevant safety implications regarding contracts with operating companies and/or marketing partners · Review and make suggestions for system and procedure enhancements · Participation in inspection and audits as required (e.g., interviews) · Participation in local or global project teams · Technical training & e-learning · Workplace shadowing · Mentoring others · Project involvement · Soft skill development activities · Application and knowledge of Departmental processes and guidelines, regulations and regulatory guidelines, contractual arrangements, product specific information and database/systems functionality to individual case processing and evaluation. · Communicate questions clearly and concisely to the appropriate audience and accompany with possible solutions. · Registered Nurse OR · Health/Biomedical Degree OR · Licensed Practical Nurse with Bachelors degree OR · Licensed Practical Nurse without Bachelors degree, but with knowledge of drug safety usually exhibited by minimum 5 years experience in pharmaceutical safety related role. · Pharmaceutical Industry Experience Preferred · Required Skills/Abilities · Intermediate Information Technology Skills · Data entry experience desired · Accountability for delivery of results · Decision making skills · Problem solving skills · Proactive approach/uses own initiative · Managing own work, ability to prioritize, plan and organize work assignments and work under strict timelines · Ability to follow guidelines, working practices etc. Experience of working with SOP/SWP’s preferred · Quality orientation, attention to detail/accuracy · Flexibility/Adaptability · Positive attitude · Good team player · Ability to work independently and to collaborate · Good written and verbal communication skills · Understanding of medical terminology · Ability to summarize medical information · Pharmaceutical industry experience · Experience with a drug safety database · Working knowledge of coding dictionaries · Practical knowledge of global regulatory AE requirements · 3 years experience in skills listed above. Please Note: Submit your resume through this posting. Please Do Not Call, we will call you. ======================================================== Pioneer Data Systems, Inc. an "Inc 500" and "NJ Technology Fast 50" company, is a preferred provider to Fortune 500 Clients nationwide. We distinguish ourselves by providing outstanding service to our clients using emerging and innovative technologies. PDS offers excellent compensation, benefits and constant flow of new challenges to its consultants. We understand that every professional has different needs, so we will work with you to determine a suitable benefit package, which includes; group medical plan (Section 125), 401K Plan, etc. We are an E-Verify Employer. For further information, please visit us at www.pioneerdata.com
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