Safety & PV Submission Spec I - Brazil Home Based

Syneos Health; Brasil; Remote; BRL 80,000 - 120,000; Full time

Job summary

Syneos Health, Inc. in Brazil seeks a Safety & PV Submission Specialist to support expedited and periodic safety report submissions to Regulatory Authorities, Ethics Committees, and Investigators.

You will ensure compliance with GCPs, GVP, and privacy guidelines, coordinating with cross-functional teams. Responsibilities include drafting and assembling safety documents, tracking submissions, and applying regulatory intelligence to safety activities while maintaining SOP/WI compliance and good

Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, or an equivalent combo of education and experience.
• Safety and pharmacovigilance experience preferred.
• Familiarity with safety databases and medical terminology preferred.
• Proficiency in MS Office and basic data handling tools.
• Ability to work independently and in a team.
• Strong communication and organizational skills.

Responsibilities

• Assists with design, preparation and assembly of expedited and periodic safety report documents.
• Maintains tracking of safety submissions.
• Fosters professional relationships with project team members.
• Applies regulatory intelligence to safety reporting activities.
• Files documents per project requirements (electronic or hard copy).
• Forwards completed safety submission documents to clients and relevant parties.
• Provides support with safety reporting project tasks.
• Maintains understanding of SOPs, WIs, GCPs, ICH guidelines, and regulatory requirements.

Skills

Communication

Teamwork

Detail-oriented

Multitasking

Organizational skills

Education

Bachelor's Degree in life science or allied field

Safety and Pharmacovigilance experience

Tools

Microsoft Office Suite

Visio

Outlook

TeamShare

Job description

Safety & PV Submission Spec I - 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.

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.