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Safety & PV Submission Spec I - At least 2 years of experience with safety submissions in clinical trials in Brazil and other countries - Brazil Home Based Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
The position is responsible for assisting with the preparation and submission of expedited and periodic safety reports to Regulatory Authorities, Ethics Committees and Investigators, adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory
guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs.
Responsibilities:
Assists with the design, preparation and assembly of the expedited and periodic safety report documents
Maintains tracking of safety submissions
Fosters constructive and professional working relationships with all project team members, internal and external
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)
Forwards completed safety submission documents to clients and other relevant parties
Provides support with miscellaneous project tasks related to safety reporting
Maintains an understanding and compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process
Qualifications:
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.
Safety and Pharmacovigilance experience preferred
Safety Database systems and moderate medical terminology preferred.
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 Excellent communication and interpersonal skills, both written and spoken Strong organizational and documentation skills Detailed oriented with a high degree of accuracy and ability to meet deadlines Good knowledge of ICH guidelines and regulations relating to Safety and Pharmacovigilance Able to make effective decisions Manage multiple priorities
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.
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. 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 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.