Sr. Safety & PV Specialist Literature Case Processing & Review

Why This Role Matters

In the pharmaceutical and clinical research industry, patient safety and pharmacovigilance (PV) compliance are critical to ensure products remain safe and effective throughout their lifecycle. A Senior Safety & PV Specialist focusing on literature case processing and review ensures that all adverse events, case reports, and safety-related literature are systematically monitored, documented, and reported in line with global regulatory standards.
This role is pivotal in identifying, evaluating, and processing individual case safety reports (ICSRs) from literature sources and clinical trials, supporting the safety management framework of the organization. By ensuring accurate and timely reporting, this position helps maintain regulatory compliance, protect patient safety, and support organizational credibility and business success.

Job Description

We are seeking an experienced and detail-oriented Senior Safety & PV Specialist – Literature Case Processing & Review to manage literature-based ICSR identification, extraction, and reporting. The role involves systematic literature surveillance, processing case reports, and ensuring adherence to global and local pharmacovigilance regulations. The candidate will collaborate with cross-functional teams, including Clinical Operations, Data Management, and Regulatory Affairs, to ensure complete safety documentation and compliance.
This is a full-time, office-based role in Gurugram or Hyderabad, India, reporting to the Program Lead/Program Director.

Key Features of the Role

· Systematic and ad-hoc literature case identification and review
· Expertise in global and local biomedical literature databases (Embase, PubMed, Medline)
· End-to-end ICSR processing, coding, and reporting
· Compliance with global pharmacovigilance standards (GVP, ICH GCP, local regulations)
· Collaboration with cross-functional teams to ensure project delivery and safety readiness
· Participation in audits, inspections, and safety-related trainings

Responsibilities

· Conduct systematic and ad-hoc literature searches in global biomedical databases (Embase, PubMed, Medline) for ICSR identification and safety-relevant information
· Extract and summarize key safety information from identified literature sources
· Create and validate literature search strategies for pharmacovigilance purposes
· Conduct local literature searches and reviews as required
· Coordinate workflows to ensure timely project delivery
· Prepare Safety Management Plans
· Participate in internal project review meetings
· Enter information into PVG quality and tracking systems for ICSR receipt and tracking
· Process ICSRs according to SOPs and project-specific safety plans:
· Triages ICSRs, evaluates data for completeness, accuracy, and regulatory reportability
· Enters data into safety databases, codes events, medical history, concomitant medications, and tests
· Compiles narrative summaries and resolves queries
· Coordinates timely reporting of expedited reports in accordance with regulatory requirements
· Reconciles safety data between clinical and safety databases
· Ensure distribution of individual expedited and periodic reports for clinical and post-marketing projects
· Provide training to Investigators on ICSR reporting
· Participate in audits/inspections as required
· Maintain regulatory and company compliance with SOPs, GCP, ICH guidelines, GVP, and relevant drug development processes
· Review and provide solutions for issues relating to program delivery or escalate as needed
· Support trend analysis by gathering and standardizing relevant information
· Act as a subject matter expert to support day-to-day troubleshooting within the team

Required Qualifications

· Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, PharmD, BDS, or BMS
· Minimum 5 years of experience in literature case processing with SME-level expertise
· Knowledge of safety database systems and medical terminology
· Strong understanding of clinical trial processes (Phases II-IV) and post-marketing safety requirements
· Familiarity with ICH GCP, GVP, and global/local safety regulations

Preferred Qualifications

· Previous experience in pharmacovigilance or PV project management
· Exposure to global literature surveillance standards and tools
· Experience participating in audits and inspections

Educational Requirements

· B.Pharm, M.Pharm, PharmD, BDS, or BMS
· Candidates with a strong foundation in pharmacovigilance or clinical safety are preferred

Experience and Skills

· 5+ years of relevant experience in literature case processing and pharmacovigilance
· Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, TeamShare, and internet-based tools
· Strong communication, presentation, and interpersonal skills
· Ability to work independently and as part of a team
· Excellent organizational skills with ability to prioritize multiple tasks and meet deadlines
· Detail-oriented with high accuracy and effective decision-making skills
· Minimal travel required (up to 10%)

Salary Insights

· Compensation: Competitive, aligned with industry standards for Senior Safety & PV Specialists in India
· Additional benefits may include health insurance, performance incentives, and professional development programs

Company Overview

Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating the delivery of therapies. With 29,000 employees across 110 countries, Syneos Health emphasizes patient-centered clinical development, regulatory excellence, and innovative solutions. The company fosters a Total Self culture, promoting diversity, inclusivity, and professional development.

FAQs

Is prior experience in literature case processing mandatory?
Yes, 5+ years of experience with SME-level knowledge is required.

Does this role involve cross-functional coordination?
Yes, regular collaboration with Clinical Operations, Data Management, and Regulatory teams is essential.

Are global pharmacovigilance frameworks relevant?
Yes, knowledge of ICH GCP, GVP, and local/global safety regulations is required.

Will the role handle ICSR reporting and database entry?
Yes, end-to-end ICSR processing, coding, and reporting is part of the role.

Is training of Investigators included?
Yes, providing ICSR reporting guidance and training is expected.

Application Tips

· Highlight experience in literature case processing and ICSR management
· Emphasize knowledge of global and local PV regulations
· Showcase proficiency in safety databases and literature search tools
· Mention experience in audits, inspections, and training