Safety & PV Specialist I

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Input data into PVG quality and tracking systems for the management and monitoring of ICSRs.

• Aid in the processing of ICSRs in accordance with SOPs and specific safety plans for projects/programs.

• Assess ICSRs by triaging and evaluating data for completeness, accuracy, and regulatory reporting requirements.

• Populate the safety database with relevant data.

• Code events, medical histories, concomitant medications, and tests.

• Create comprehensive narrative summaries.

• Identify information needing clarification and follow up until all queries are resolved satisfactorily.

• Assist with prompt, consistent, and precise expedited safety reporting.

• Maintain tracking of safety for assigned tasks.

• Conduct literature screening and reviews for safety purposes.

• Execute drug coding and manage the drug dictionary.

• Carry out MedDRA coding.

• Validate and submit xEVMPD product records, including the coding of indication terms using MedDRA.

• Manually recode any product and substance terms from ICSRs that have not been coded.

• Identify and handle duplicate ICSRs.

• Engage in activities related to SPOR/IDMP.

• Perform quality reviews of ICSRs.

• Ensure that relevant documents are submitted to the TMF and Pharmacovigilance System Master File when appropriate.

• Uphold compliance with SOPs, WIs, regulations, GCP, ICH guidelines, GVP, project/program plans, and the drug development process.

• Cultivate professional relationships with project team members.

• Participate in audits as necessary.

• Utilize Syneos Health regulatory intelligence in safety reporting activities.

⛳️ Requirements

• Bachelor’s Degree in life sciences, nursing, pharmacy, or a comparable combination of education and experience.

• Knowledge of safety database systems is essential.

• Familiarity with medical terminology is required.

• Strong understanding of clinical trial processes across Phases II–IV and/or post-marketing safety obligations.

• Comprehension of ICH GCP, GVP, and safety/pharmacovigilance regulations.

• Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint.

• Proficient in Visio.

• Skilled in Outlook email.

• Experienced with Team Share or a similar management/shared content/workspace system.

• Ability to work autonomously as well as collaboratively in a team setting.

• Exceptional written and verbal communication skills along with strong interpersonal abilities.

• Good organizational skills with the capability to prioritize multiple tasks and projects.

• Detail-oriented, highly accurate, and capable of meeting deadlines.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive workplace culture.

• Access to extensive resources, including emerging technologies, data, scientific knowledge, and sharing opportunities.

• Diverse career paths and employment opportunities.

• Reasonable accommodations provided when appropriate.