Job Description - Principal Safety & PV Specialist - Bilingual French Canadian / English (21010098)
Principal Safety & PV Specialist - Bilingual French Canadian / English-(21010098)
Principal Safety & Pharmacovigilance Specialist
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
#SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s 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 – we’re able to create a place where everyone feels like they belong.
Works independently to oversee day to day Safety and Pharmacovigilance (SPVG) activities on assigned projects/programs.
Exercises independent judgement to troubleshoot and resolve project issues and to identify areas for improvement.
Develops innovative solutions to meet unique, client-specific requirements.
Supports management/lead in reviewing and presenting prepared information at project or departmental review meetings.
Develops training materials, conducts training presentations and on-the-job-training for appropriate departmental teams.
Participates in and/or leads departmental initiatives to increase efficiencies and optimize processes.
Serves as a subject matter expert in SPVG.
Presents at client/investigator meetings.
Assists in the tracking and measuring of program/project and team progress through collection of cycle time metrics and other key performance indicators (KPIs). Proposes solutions to issues that may arise and strategies to improve metrics/cycle times.
Leads teams of subject matter experts in the development and review of Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new or existing processes.
Participate in audits/inspections as the SPVG SME.
Maintains understanding and compliance with SOPs, WIs, global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, study/program plans and the drug development process.
What we’re looking for
Bachelor’s 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
Demonstrated Fluency in French and English (written and verbal)
Previous experience working as a Local Safety Officer
Safety Database systems experience and knowledge of medical terminology required
Excellent understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP and regulations related to Safety and Pharmacovigilance
Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members, and other internal staff members
Demonstrates initiative on the individual and team level; ability to work effectively within a team to attain a shared goal
Strong organizational skills with proven ability to handle multiple tasks
Strong presentation, documentation, and interpersonal skills
Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet
Ability to deliver high quality work in a dynamic environment
Minimal travel may be required (10%)
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.
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 Job Description. 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.
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