Description Senior SPVG Scientific Specialist Come discover what our 25,000+ employees already know: work here matters everywhere. We\xe2\x80\x99re a growing and evolving biopharmaceutical industry leader, which means you\xe2\x80\x99ll have endless opportunities to work with experts around the world and build the career you\xe2\x80\x99ve dreamed of.
As a part of the Syneos Health team, you\xe2\x80\x99ll help us deliver results for a rewarding reason \xe2\x80\x93 we improve patients\xe2\x80\x99 lives around the world. Because to us, a patient isn\xe2\x80\x99t just a number, they\xe2\x80\x99re our family, friends, and neighbors.
Why Syneos Health

• #SyneosHealthLife means we\xe2\x80\x99re committed to our Total Self culture \xe2\x80\x93 where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person\xe2\x80\x99s unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it \xe2\x80\x93 you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That\xe2\x80\x99s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives \xe2\x80\x93 we\xe2\x80\x99re able to create a place where everyone feels like they belong.

Job responsibilities

• Collaborates with the Client and internal project management associates for safety and pharmacovigilance activities including (but not limited to) literature screening and review, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding, case processing or review of individual case safety reports, authoring or review of aggregate reports and ongoing safety evaluation activities. The processing of information may include filtering, cleaning, migrating, analysing, reporting, filing or publication of data and information.
• Participates in project launch activities for safety and pharmacovigilance programs
• Maintains safety tracking for assigned activities
• Provides support and advice on safety and pharmacovigilance program issues to project team/Sponsor as required
• Fosters constructive and professional working relationships with all project team members, internal and external
• Assists in the preparation of data for internal project review meetings and participates as required
• May be responsible for distributing and monitoring team workload
• Participates in audits as required/appropriate
• Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities
• Files documents according to project specific requirements (electronically or in hard copy as applicable)
• Provides support with miscellaneous project tasks related to safety and pharmacovigilance activities
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Program Specific FIle or Pharmacovigilance System Master File for post-marketing programs as appropriate
• Assists in the tracking and measuring of program/project and team progress through collection of cycle time metrics and other key performance indicators (KPIs).
• Participates in audits as required/appropriate
• Provides support with miscellaneous project tasks related to safety and pharmacovigilance activities
• Maintains an understanding and compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, the drug development process and GVP

Qualifications What we\xe2\x80\x99re looking for

• Bachelor\xe2\x80\x99s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
• Should have 5+ years of working experience in Literature review
• should have working experience in QC related activities
• Should have working experience in PubMed, EMBASE
  
  • Knowledge of medical terminology required
  • Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet.
  • Ability to work independently and in a team environment
  • Ability to successfully prioritize and work on multiple tasks
  • Good 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
  • Able to make effective decisions
  • 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

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the . The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.