Peak Performers has partnered with a global biopharmaceutical company to assist in their search for a Drug Safety Senior Specialist. In this contract position, you will be responsible for the processing of adverse event reports that include but are not limited to the receipt, evaluation, reviewing and reporting of adverse event information for marketed and investigational products in accordance with ICH guidelines and applicable regulatory requirements including the FDA and applicable licensing or partnership agreements.
Major duties
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Monitor and oversee cases throughout their lifecycle, collaborating with clinical, regulatory, and contract research organizations (CROs) to independently ensure the execution of post-market and clinical safety pharmacovigilance tasks.
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Conduct safety data verification and apply clinical judgment when coding adverse events, medical histories, and medication information. Proficiently synthesize intricate clinical data into comprehensive, accurate reports.
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Actively pursue event resolution by following up on cases, conducting Serious Adverse Event (SAE) reconciliation, and ensuring the timely closure of cases.
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Implement continuous quality improvement measures to maintain data consistency and uphold a high level of data quality across various products.
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Play a role in creating and documenting industry-standard operating procedures and processes for pharmacovigilance activities, including the development of Safety Management Plans for assigned studies, ensuring consistent and timely processing of adverse event reports.
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Aid in addressing inquiries from health authorities and external sources, and provide requested safety information for Regulatory submissions such as Investigational New Drug (IND) safety reports, Annual Safety reports, Periodic Safety Update Reports (PSUR), and clinical study reports.
What are we looking for
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Possess a clinical degree (e.g., RPh/PharmD, BSN, RN).
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Have 3-5 years of experience in drug safety or clinical safety.
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Demonstrate a minimum of two years of clinical experience in a medical setting and a solid understanding of medical and pharmacological principles.
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Preferred experience in processing Oncology cases.
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Exhibit knowledge of both domestic and international regulatory safety reporting requirements, including familiarity with FDA/ICH guidance related to pharmacovigilance and Good Clinical Practices.
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Proficiency in using commercial safety application databases such as Clintrace, ArisG, or Argus. Familiarity with clinical trial databases like Trailmaster is a plus.
About this position
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Rate: $42.00/hour (W-2)
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Length of engagement: ~6 months
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Days/Hours: Monday-Friday/8am-5pm
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Location: Waltham, MA
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Hybrid - 3 days onsite
The Peak Performers difference
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Excellent medical health, dental & vision insurance at 60 days
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Our employees may choose to participate in a 403(b) retirement plan
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Qualified applicants with chronic medical conditions and/or disabilities receive priority placement
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We pay weekly through direct deposit
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In business since 1994 and thousands of job placements
All employment offers are contingent on the successful completion of a pre-employment criminal background check, in compliance with all applicable federal and state laws.
Applicants for employment with Peak Performers must possess work authorization that does not require sponsorship for a visa now or in the future.
Peak Performers is an equal opportunity employer and will consider all applicants without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. Peak Performers does not accept unsolicited resumes from headhunters, recruitment agencies or fee-based recruitment services.
JH820099417

LI-Hybrid

prvl

Please refer the Job description for details