Safety & PV Submission Spec I - Brazil Home Based

7254 Syneos Health Brasil Ltda.; Brasil; Remote; BRL 60,000 - 90,000; Full time

Job summary

Syneos Health Brasil Ltda. is seeking a Safety & PV Submission Spec I to support safety reporting activities from a home-based role in Brazil. The position involves assisting with safety report preparation, tracking submissions, and ensuring regulatory alignment with SOPs and ICH guidelines.

The role requires a life sciences degree, PV experience preferred, and proficiency with MS Office. Strong communication and organizational skills are essential for success in a collaborative global team.

Qualifications

• Bachelor’s degree in life science or equivalent; relevant healthcare background preferred.
• Experience in safety/pharmacovigilance is a plus.
• Strong communication, documentation and regulatory knowledge.

Responsibilities

• Assist design, prep and assemble safety reports.
• Maintain tracking of safety submissions.
• Support with safety reporting tasks and SOPs compliance.

Skills

Communication skills

Teamwork

Organizational skills

Attention to detail

Prioritization

Independent work

Education

Bachelor’s Degree in life science

Registered nurse

Pharmacist

Tools

Microsoft Office

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.

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.
• We are continuously building the company we all want to work for and our customers want to work with.

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.

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.

Learn more about Syneos Health. http://www.syneoshealth.com

Job 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.

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.

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.

Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much‑needed therapies to those who need them most.

A career with Syneos Health means your everyday work improves patients’ lives around the world.

Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life‑changing therapies worldwide.