# Safety & PV Specialist II - Literature Case Processing **Company**: Syneos Health **Location**: Gurugram, IND **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Gurugram/Safety---PV-Specialist-II---Literature-Case-Processing_25113146?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_cd7f534a-72e ## 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 ## Skills ### Required - Pharmacovigilance - Literature Case Processing - Medical Literature Monitoring - MedDRA coding - drug coding - ICSR processing - data entry - narrative writing - case management - safety databases - medical terminology - clinical trials - post-marketing safety requirements - ICH-GCP - GVP - pharmacovigilance regulations - quality review activities - regulatory compliance processes - Microsoft Office Suite --- Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Gurugram/Safety---PV-Specialist-II---Literature-Case-Processing_25113146?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)