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Principal Safety
3 months ago
Description
Principal Safety & Pharmacovigilance Specialist
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success.
We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
Every day we perform better because of how we work together, as one team, each the best at what we do.
We bring a wide range of talented experts together across a wide range of business-critical services that support our business.
Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life.Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- 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.
Job responsibilities
- 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, clientspecific requirements.
- Supports management/lead in reviewing and presenting prepared information at project or departmental review meetings.
- Develops training materials, conducts training presentations and onthejobtraining for appropriate departmental teams.
- Participates in and/or leads departmental initiatives to increase efficiencies and optimize processes.
- 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.
- 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.
Qualifications
What we're looking for
- Should be a HCP.
- Must have minimum experience of 8 Years in Pharmacoviglance domain.
- Should have strong experience on
Workflow Management, Quality Review & Training needs of projectteam.
Argus Safety Database systems experience is Must.
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Must have good experience on Literature, PMS & CT Cases.
- Safety Database systems experience and knowledge of medical terminology required
- Excellent understanding of clinical trial process across Phases II-IV and/or postmarketing 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
- Ability to deliver high quality work in a dynamic environment
- Minimal travel may be required (10%)
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
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 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