PHARMAFull-time
Safety & PV Specialist I - Literature review
By Admin · Pharmacovigilance & Drug Safety
DELHI NCR (IN)ONSITEPOSTED: 9/2/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
ROLE DEFINITION & RESPONSIBILITIES
Job Overview
Full-time Safety & Pharmacovigilance Specialist I position focused on literature review and pharmacovigilance operations.
Office-based role located in Gurugram, India.
Supports the receipt, triage, processing, review, coding, quality control and regulatory reporting of Individual Case Safety Reports (ICSRs).
Supports pharmacovigilance literature screening and review activities.
Works in accordance with company Standard Operating Procedures, Work Instructions, project-specific safety plans and applicable global regulatory requirements.
Contributes to safety surveillance activities supporting clinical trials and post-marketing pharmacovigilance programs.
ICSR Processing & Case Management
Enter information into pharmacovigilance quality and tracking systems for the receipt and tracking of ICSRs.
Assist in processing Individual Case Safety Reports according to Standard Operating Procedures and project or program-specific safety plans.
Triage incoming ICSRs and assess case information for appropriate processing.
Evaluate ICSR data for completeness, accuracy and regulatory reportability.
Enter required case information into the applicable safety database.
Maintain accurate safety tracking for assigned activities.
Identify missing or incomplete information requiring follow-up.
Generate and manage queries to obtain required information.
Follow up on outstanding queries until the required information is obtained and queries are satisfactorily resolved.
Support the preparation of complete and accurate case documentation.
Medical Coding & Safety Data Management
Code adverse events and other relevant medical information.
Code medical history information.
Code concomitant medications.
Code relevant tests and associated safety information.
Perform MedDRA coding as required.
Support drug coding activities.
Maintain drug dictionary information.
Perform manual recoding of previously un-recoded product and substance terms arising from ICSRs.
Apply appropriate coding standards to support accurate and consistent safety data.
Support validation and quality of coded safety information.
Literature Screening & Review
Perform literature screening for safety-related information.
Review scientific and medical literature to identify relevant pharmacovigilance information.
Support literature review activities in accordance with applicable safety procedures and project requirements.
Evaluate literature-derived information for relevance to safety surveillance and pharmacovigilance processes.
Support accurate documentation and processing of identified safety information.
Regulatory Reporting
Assist in generating timely, consistent and accurate expedited safety reports.
Support safety reporting activities in accordance with applicable regulatory requirements.
Assess ICSR information for regulatory reportability.
Apply Syneos Health safety reporting regulatory intelligence to assigned safety reporting activities.
Maintain awareness of applicable global drug, biologic and device regulations.
Support compliance with applicable pharmacovigilance reporting requirements.
Product Data & Regulatory Activities
Validate xEVMPD product records.
Support submission of xEVMPD product records.
Ensure appropriate coding of indication terms using MedDRA.
Perform activities associated with product and substance information management.
Support SPOR and IDMP-related activities.
Assist with maintaining accurate regulatory product information and terminology.
ICSR Quality & Duplicate Management
Perform quality review of Individual Case Safety Reports.
Identify potential duplicate ICSRs.
Support identification, assessment and management of duplicate case reports.
Maintain high levels of accuracy during case processing and quality review.
Ensure safety case information meets applicable procedural and quality expectations.
Documentation & File Management
Ensure relevant documents are submitted to the Trial Master File according to company SOPs and sponsor requirements for clinical trials.
Ensure applicable safety documentation is maintained appropriately.
Support documentation requirements for the Pharmacovigilance System Master File for post-marketing programs.
Follow document management procedures established by company and sponsor requirements.
Regulatory & Quality Standards
Maintain understanding of and compliance with Standard Operating Procedures.
Follow applicable Work Instructions.
Maintain knowledge of global regulations related to drugs, biologics and medical devices.
Apply Good Clinical Practice requirements where relevant.
Maintain understanding of ICH guidelines.
Apply Good Pharmacovigilance Practice requirements.
Understand and follow project and program-specific plans.
Maintain awareness of the drug development process.
Support compliance across clinical trial and post-marketing safety activities.
Audit & Inspection Support
Participate in audits when required or appropriate.
Support audit readiness through accurate safety documentation and adherence to established procedures.
Maintain quality and compliance standards in assigned pharmacovigilance activities.
Team Collaboration
Foster constructive and professional working relationships with internal project team members.
Collaborate effectively with external project stakeholders where required.
Work independently while managing assigned pharmacovigilance responsibilities.
Work effectively as part of a collaborative team environment.
Communicate clearly in written and spoken interactions.
Prioritize multiple tasks and projects while meeting established deadlines.
Qualifications & Education
Bachelor's Degree in Life Sciences, or
Registered Nurse qualification, or
Pharmacist qualification, or
Equivalent combination of education and experience providing the knowledge, skills and abilities required for the position.
Safety database systems knowledge is required.
Knowledge of medical terminology is required.
Good understanding of clinical trial processes across Phase II, Phase III and Phase IV studies and/or post-marketing safety requirements.
Understanding of ICH-GCP and GVP requirements.
Knowledge of regulations related to Safety and Pharmacovigilance is required.
Technical Skills
Experience or knowledge of pharmacovigilance safety database systems.
Knowledge of medical terminology.
Proficiency in Microsoft Word.
Proficiency in Microsoft Excel.
Proficiency in Microsoft PowerPoint.
Working knowledge of Microsoft Visio.
Proficiency in Outlook and email communication.
Ability to work with Team Share or similar management, shared-content or workspace platforms.
Ability to use internet-based resources for work activities.
Ability to learn and apply safety coding and regulatory terminology requirements.
Professional & Functional Skills
Ability to work independently.
Ability to work effectively within a team environment.
Excellent written communication skills.
Excellent spoken communication skills.
Strong interpersonal skills.
Good organizational abilities.
Proven ability to prioritize work effectively.
Ability to manage multiple tasks and projects simultaneously.
Strong attention to detail.
High degree of accuracy.
Ability to work to deadlines.
Company & Career Environment
Syneos Health operates as a fully integrated life sciences services organization supporting drug development and commercialization.
Employees work across clinical development activities with exposure to global life sciences and healthcare programs.
The company highlights career development and progression opportunities.
Employees may receive supportive and engaged line management.
Technical and therapeutic-area training opportunities are emphasized.
The company highlights peer recognition and total rewards programs.
Syneos Health promotes collaboration, professional development and an inclusive working culture.
The organization reports experience supporting a significant proportion of novel FDA-approved drugs and EMA-authorized products, providing exposure to large-scale global drug development and safety operations.
REQUIRED VERIFIED SKILLS
Pharmacovigilance
Safety Case Processing
ICSR Processing
ICSR Triage
ICSR Data Review
Safety Database Systems
Medical Terminology
Safety Data Entry
Adverse Event Coding
Medical History Coding
Concomitant Medication Coding
MedDRA Coding
Drug Coding
Drug Dictionary Maintenance
Literature Screening
Literature Review
Narrative Writing
Case Narrative Compilation
Query Management
Query Follow-up
Expedited Safety Reporting
Regulatory Reportability Assessment
ICSR Quality Review
Duplicate ICSR Management
xEVMPD Validation
xEVMPD Submission
Indication Coding
Product and Substance Recoding
SPOR
IDMP
Trial Master File Management
Pharmacovigilance System Master File
SOP Compliance
Work Instructions
ICH-GCP
GVP
Global Safety Regulations
Clinical Trial Processes
Post-Marketing Safety
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Microsoft Visio
Outlook
Attention to Detail
Accuracy
Time Management
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
No salary range or compensation figures are disclosed in the official job posting. Compensation may depend on the candidate's educational background, pharmacovigilance experience, safety database knowledge, medical terminology expertise and Syneos Health's internal compensation structure for Gurugram-based roles. The company highlights a total rewards program, career development and progression opportunities, supportive line management, technical training, therapeutic-area training and peer recognition. Candidates should discuss fixed salary, performance incentives, insurance and healthcare benefits, leave benefits, learning support and other applicable total rewards during the recruitment process.
ORGANIZATION CONTEXT & CULTURE
Syneos Health is a leading fully integrated biopharmaceutical solutions organization. They provide end-to-end clinical and commercial solutions designed to accelerate the development and commercialization of new therapies worldwide. The company combines clinical development, medical affairs, and commercialization expertise to help clients bring innovative treatments to patients faster.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare Services
EXPECTED CAREER ROADMAP
This Safety & PV Specialist I role offers a strong entry pathway into specialized pharmacovigilance and drug safety careers. Experience gained in ICSR processing, medical coding, MedDRA, literature surveillance, safety databases, regulatory reporting and quality review can support progression into Safety & PV Specialist II, Senior Safety Specialist, Senior Drug Safety Associate, Pharmacovigilance Scientist or Case Processing Lead roles. Developing expertise in xEVMPD, SPOR, IDMP, post-marketing surveillance and global regulatory requirements can also create opportunities in regulatory safety operations, signal management, aggregate safety reporting, pharmacovigilance quality, safety systems and global drug safety project management. Exposure to clinical trial and post-marketing safety requirements provides a foundation for long-term career growth across CROs, pharmaceutical companies, biotechnology organizations and global life sciences services providers.
APPLICATION ADVISORY
Highlight your Life Sciences, Pharmacy, Nursing or equivalent qualification clearly on your resume. Emphasize any academic, internship or professional exposure to pharmacovigilance, adverse event processing, clinical research, clinical trials or drug safety. Include practical knowledge of ICSR workflows, safety databases, medical terminology, MedDRA and ICH-GCP/GVP wherever applicable. If you have literature review experience, clearly explain how you screened, evaluated or documented medical and scientific information. Demonstrate strong attention to detail using examples involving data review, quality checks or error identification. Prepare for interviews by reviewing the ICSR lifecycle, case triage, seriousness and expectedness concepts, medical coding, MedDRA hierarchy, duplicate case identification, follow-up queries and expedited safety reporting. Also be prepared to demonstrate proficiency in Excel, Word, PowerPoint, Outlook and your ability to prioritize multiple safety cases and deadlines.
RECOMMENDED TRAINING
1/5
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