Safety & PV Specialist I/II

🔥 0 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Safety Specialist

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs • Assist in processing ICSRs according to SOPs and project/program-specific safety plans • Triage ICSRs and evaluate data for completeness, accuracy, and regulatory reportability • Enter data into safety databases • Code events, medical history, concomitant medications, and tests • Compile complete narrative summaries • Identify information to be queried and follow up until queries are satisfactorily resolved • Assist in generating timely, consistent, and accurate expedited reports according to regulatory requirements • Maintain safety tracking for assigned activities • Perform literature screening and review for safety • Perform drug coding and maintain the drug dictionary • Perform MedDRA coding • Validate and submit xEVMPD product records, including coding indication terms using MedDRA • Manually recode unrecoded product and substance terms from ICSRs • Identify and manage duplicate ICSRs • Perform activities related to SPOR/IDMP • Conduct quality review of ICSRs • Ensure relevant documents are submitted to the Trial Master File and Pharmacovigilance System Master File as appropriate • Maintain compliance with SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans, and the drug development process • Foster professional working relationships with internal and external project team members • Participate in audits as required • Apply Syneos Health regulatory intelligence to safety reporting activities

🎯 Requirements

• Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience • Safety Database systems and knowledge of medical terminology • Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance • Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, Outlook, Team Share (or another management/shared content/workspace) and internet • Ability to work independently and in a team environment • Excellent written and spoken communication and interpersonal skills • Good organizational skills with proven ability to prioritize and work on multiple tasks and projects • Detail oriented with a high degree of accuracy and ability to meet deadlines

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations, when appropriate, under the Americans with Disabilities Act