Safety & PV Specialist II - CT Case processing Team

Description

Safety & PV Specialist II - CT Case processing Team

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

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

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. 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. 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.

Summary

Job Summary We are seeking an experienced Pharmacovigilance professional with strong expertise in Clinical Trial (CT) case processing and Medical Literature Monitoring (MLM). The successful candidate will be responsible for end-to-end ICSR management, literature review, coding activities, quality review, and regulatory compliance while supporting global safety operations and delivery excellence. Key Responsibilities Perform end-to-end processing of Individual Case Safety Reports (ICSRs), including case intake, data entry, coding, narrative writing, follow-up, and case completion within established timelines. Enter and maintain safety information in Pharmacovigilance databases and tracking systems, ensuring accuracy, completeness, and compliance with project requirements. Process literature-derived ICSRs in accordance with applicable SOPs, safety management plans, and regulatory requirements. Conduct comprehensive literature screening, Medical Literature Monitoring (MLM), and literature review activities to identify potential adverse events and reportable safety information. Evaluate case data for medical and regulatory completeness, accuracy, consistency, and reportability. Perform MedDRA coding, drug coding, dictionary maintenance, and related coding activities as required. Conduct quality review of safety cases to ensure adherence to regulatory guidelines, client expectations, and internal quality standards. Identify, reconcile, and manage duplicate safety cases across safety databases and tracking systems. Support regulatory data management activities including xEVMPD, SPOR, and IDMP-related validation and submission processes. Assist with manual recoding of products, substances, indications, and related safety data when required. Maintain accurate and audit-ready safety documentation in accordance with company, client, and regulatory requirements. Ensure compliance with SOPs, Work Instructions, GVP, ICH-GCP guidelines, global pharmacovigilance regulations, and project-specific procedures. Participate in audits, inspections, quality reviews, and continuous process improvement initiatives. Apply pharmacovigilance expertise and regulatory intelligence to support compliant safety reporting and lifecycle management activities. Collaborate effectively with cross-functional teams and global stakeholders to ensure successful project delivery and operational excellence. Qualifications & Experience Required Qualifications M.Pharm, PharmD, B.Pharm, BDS, or an equivalent healthcare/life sciences qualification. 4-7 years of Pharmacovigilance experience with a strong focus on Clinical Trial (CT) case processing. Demonstrated experience in ICSR processing, case management, safety data entry, narrative writing, and follow-up activities. Working knowledge of safety databases, MedDRA coding, drug dictionaries, and medical terminology. Strong understanding of Clinical Trials, Pharmacovigilance regulations, ICH-GCP, GVP, and post-marketing safety requirements. Experience conducting quality review activities and ensuring regulatory compliance. Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook. Ability to work independently while collaborating effectively within global and cross-functional teams. Excellent written and verbal communication skills. Strong analytical, organizational, and prioritization skills with the ability to manage multiple deliverables simultaneously. High attention to detail, accuracy, quality, and compliance. Preferred Skills Experience with literature case processing and Medical Literature Monitoring (MLM). Exposure to xEVMPD, SPOR, and IDMP requirements. Knowledge of duplicate management and reconciliation activities. Experience supporting audits, inspections, and regulatory submissions.