Safety & PV Specialist I

🕒 May 26

🇨🇳 China – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Safety Specialist

Where this job comes from

Posted on Syneos Health's careers page, not through a job board

First seen by Remote Rocketship May 26

Logo of Syneos Health

Syneos Health

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 • Assists in processing of ICSRs according to SOPs • Triages ICSRs, evaluates ICSR data for completeness • Codes events, medical history, concomitant medications • Compiles complete narrative summaries • Assists in generation of timely reports • Maintains safety tracking for assigned activities • Performs literature screening and review for safety • Quality review of ICSRs • Ensures all relevant documents are submitted to the TMF

🎯 Requirements

• Bachelor’s Degree in life science, registered nurse, pharmacist or equivalent • Safety Database systems knowledge • Good understanding of clinical trial process across Phases II-IV • ICH GCP, GVP and regulations related to Safety and Pharmacovigilance • Proficiency in Microsoft Office Suite • Ability to work independently and in a team environment • Excellent communication and interpersonal skills

🏖️ Benefits

• career development and progression • supportive and engaged line management • technical and therapeutic area training • peer recognition • total rewards program • Total Self culture

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