Description
Syneos Health is seeking a Safety & PV Specialist II - Literature Case Processing. As a member of the Clinical Solutions team, you will act with a drug development mindset, applying your years of experience and deep expertise to truly understand customer needs and represent those in the solutions you shape.
Job Responsibilities
- Enter information into PV quality and tracking systems for receipt and tracking of ICSRs
- Process literature-derived ICSRs according to SOPs and project-specific safety plans
- Evaluate case data for completeness, accuracy, and regulatory reportability
- Conduct data entry, coding, narrative writing, and follow-up activities as required
- Perform comprehensive literature screening, review, and Medical Literature Monitoring (MLM) activities to identify and process potential adverse events
- Maintain safety tracking systems and ensure timely completion of assigned activities and deliverables
- Conduct MedDRA coding, drug coding, and maintenance of drug dictionaries as required
- Perform quality review of ICSRs and ensure compliance with project and regulatory requirements
- Identify, reconcile, and manage duplicate safety cases
- Support validation and submission activities related to xEVMPD, SPOR, and IDMP requirements
- Assist with manual recoding of products, substances, and indication terms when required
- Ensure all relevant safety documentation is maintained and filed appropriately in accordance with company and client requirements
- Maintain compliance with SOPs, Work Instructions, GVP, ICH-GCP guidelines, global safety regulations, and project-specific procedures
- Participate in audits, inspections, and quality improvement initiatives as required
- Apply regulatory intelligence and pharmacovigilance knowledge to safety processing and reporting activities
- Foster effective working relationships with internal and external stakeholders and contribute to a collaborative team environment
Qualifications
- 4-7 years of Pharmacovigilance experience, including significant experience in Literature Case Processing and Medical Literature Monitoring (MLM)
- M.Pharm, PharmD, B.Pharm, BDS, or equivalent healthcare-related qualification
- Strong hands-on experience in ICSR processing, literature surveillance, data entry, narrative writing, and case management
- Working knowledge of safety databases, MedDRA coding, and medical terminology
- Good understanding of clinical trials, post-marketing safety requirements, ICH-GCP, GVP, and pharmacovigilance regulations
- Experience in quality review activities and regulatory compliance processes
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Outlook, and other collaborative platforms
- Ability to work independently and effectively within global teams
- Excellent written and verbal communication skills
- Strong organizational, analytical, and prioritization skills with the ability to manage multiple activities simultaneously
- Detail-oriented with a high degree of accuracy and commitment to quality and compliance