Safety Specialist II - Clinical Trial Exp (Must have) - HYBRID

Syneos Health; Tlalnepantla; Hybrid; MXN 555,144 - 832,716; Full time

Benefits offered by this job

Career development and progression

Diversity and inclusion initiatives

Supportive management

Job summary

A leading biopharmaceutical solutions organization is seeking a Safety Specialist II to manage safety and pharmacovigilance projects in a hybrid work environment. The role involves processing individual case safety reports (ICSRs), maintaining data integrity, and ensuring compliance with global regulations. Ideal candidates will have strong skills in data management and regulatory compliance, enhancing safety reporting practices. This full-time position offers opportunities for career development in a supportive environment.

Qualifications

• Ability to manage data and ensure compliance with regulations.
• Experience in pharmacovigilance activities and quality reviews.
• Familiarity with safety databases and coding systems.

Responsibilities

• Enter information into PVG quality and tracking systems.
• Assist in the preparation of safety management plans.
• Process individual case safety reports according to SOPs.
• Coordinate with data management regarding safety data reconciliation.

Skills

Data management

Regulatory compliance

Pharmacovigilance

Quality review

Job description

Overview

Safety Specialist II - HYBRID - ARG

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. 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 accelerate the delivery of therapies, because we are passionate to change lives.

Work Here Matters Everywhere

What we offer

• Career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• Committed to a Total Self culture – authentic environments where you can be yourself and care for our people.
• Diversity of thoughts, backgrounds, cultures, and perspectives to foster belonging.

Job Responsibilities

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
• Assist in the preparation of project plans such as Safety Management Plan.
• Set-up, delivery and close-out of safety and pharmacovigilance projects.
• Process ICSRs according to SOPs and project/program-specific safety plans.
• Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability.
• Enter data into safety database. Code events, medical history, concomitant medications, and tests.
• Compile complete narrative summaries and assess information to be queried, following up until information is obtained and queries are resolved.
• Contribute to timely, consistent, and accurate reporting of expedited reports in accordance with regulatory requirements.
• Coordinate with data management regarding reconciliation of safety data between clinical and safety databases.
• Maintain safety tracking for assigned activities.
• Perform literature screening and review for safety, drug coding, maintenance of drug dictionary, and MedDRA coding as required.
• Validate and submit xEVMPD product records, including coding of indication terms using MedDRA; manual recoding of un-recoded terms arising from ICSR.
• Identify and manage duplicate ICSRs; participate in SPOR/IDMP activities.
• Quality review of ICSRs and of peers’ work; serve as a subject matter expert in SPVG with mentoring and training for new hires.
• Foster constructive relationships with project team members; apply regulatory intelligence to safety reporting activities.
• Ensure distribution of required individual expedited and periodic reports to the Safety Submissions team when contracted to submit reports.
• Participate in audits/inspections as required; submit relevant documents to TMF and pharmacovigilance system files as appropriate.
• Maintain understanding and compliance with SOPs, WIs, global regulations, GCP, ICH guidelines, GVP, and project plans.

Details

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Management and Manufacturing

Additional Information

Summary: Performs safety and pharmacovigilance program delivery activities including collection, processing, and reporting of ICSRs, literature screening and review for safety, drug coding, MedDRA coding, data management activities, and preparation of expedited and periodic safety reports, while adhering to data privacy and regulatory guidelines. The processing of information may include filtering, cleaning, migrating, analyzing, reporting, filing or publication of data.

For more information about Syneos Health, visit: http://www.syneoshealth.com