Safety & PV Specialist I

🕒 May 26

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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 ICSR as required • Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required • Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability • Enters data into safety database • Codes events, medical history, concomitant medications, and tests • Compiles complete narrative summaries • Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved • Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements • Maintains safety tracking for assigned activities • Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required • Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA • Manual recoding of un-recoded product and substance terms arises from ICSRs • Identification and management of duplicate ICSRs • Activities related to SPOR / IDMP • Quality review of ICSRs • Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate • Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process • Fosters constructive and professional working relationships with all project team members, internal and external • Participates in audits as required/appropriate • Applies safety reporting regulatory intelligence maintained by Syneos Health to all 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 required • 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, email (Outlook), Team Share (or another management/shared content/workspace) and internet • Ability to work independently and in a team environment • Excellent communication and interpersonal skills, both written and spoken • 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

• supportive and engaged line management • technical and therapeutic area training • peer recognition • total rewards program