Safety & PV Specialist I - Brazil Remote

Syneos Health, Inc.; España; Hybrid; PHP 5,025,000 - 7,538,000; Full time

Job summary

Syneos Health remote opportunity involves working in clinical pharmacovigilance to ensure quality data handling, safety tracking, and regulatory compliance. You will enter IC SR data, triage reports, code events, and prepare narrative summaries for expedited reporting, while maintaining quality across TMF submissions and post-marketing records.

The role requires meticulous data management, familiarity with MedDRA coding, and adherence to SOPs, GCP, ICH guidelines, and pharmacovigilance best

Responsibilities

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
• Triages ICSR, evaluates data for completeness, accuracy, and regulatory report ability.
• Enters data into safety database and codes events, medical history, and tests.
• Compiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
• Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Maintains safety tracking for assigned activities.
• Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.
• Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
• Manual recoding of un-recoded product and substance terms arises from ICSRS.

Job description

Updated: Today
Location: Remote, SP, Brazil
Job ID:25112417

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

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of IC SRS according to Standard Operating Procedures (SOPs) and project/program‑specific safety plans as required. Triages ICSR, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database. Codes events, medical history, concomitant medications, and testsCompiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Maintains safety tracking for assigned activities.
• Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.
• Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
• Manual recoding of un‑recoded product and substance terms arises from IC SRS.
• Identification and management of duplicate IC SRS.
• Activities related to SPOR / IDMP.
• Quality review of IC SRS.
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post‑marketing programs as appropriate.
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.