PHARMAFull-time
Safety & PV Specialist (SS I / SS II / Sr SS) - Night Shift
HYDERABAD (IN)ONSITEPOSTED: 8/20/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
ICSR Case Processing & Triage: Enter information into PVG quality and tracking systems for receipt and tracking of Individual Case Safety Reports (ICSRs). Triage ICSRs, evaluate ICSR data for completeness, accuracy, and regulatory reportability, and enter data into safety databases.
Medical Coding & Narrative Writing: Code events, medical history, concomitant medications, and diagnostic tests. Compile complete narrative summaries and identify information to be queried, following up until queries are satisfactorily resolved.
Quality Check & Literature Review: Perform quality review of ICSRs, manual recoding of un-recoded terms, literature screening, and duplicate ICSR management. Perform validation and submission of xEVMPD product records.
Compliance & Audits: Ensure all relevant documents are submitted to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF). Maintain strict compliance with SOPs, GCP, ICH guidelines, and GVP standards while participating in regulatory audits.
Technical & Domain Standards
Safety Systems & Coding: Expertise in ICSR processing, MedDRA coding, safety database entry, xEVMPD submission, and SPOR / IDMP frameworks.
Regulatory Compliance: Adherence to global drug, biologic, and device regulations, Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP), and ICH guidelines.
Educational Eligibility: Professional qualification required in B. Pharm, M. Pharm, BDS, BMS, or MBBS (BSc and MSc degrees are excluded).
Leadership & Impact
Quality Assurance Leadership: Conduct high-standard quality checks (QC) and quality reviews of ICSR cases to guarantee regulatory compliance for global drug portfolios.
Cross-Functional Synergy: Foster constructive relationships across multidisciplinary project teams and apply safety reporting regulatory intelligence to all PV operations.
Benefits & Total Rewards
Professional Development: Structured career growth paths supported by line management, technical training, and therapeutic area certifications.
Total Rewards: Competitive total rewards package, peer recognition programs, night shift allowance, and an inclusive Total Self culture.
REQUIRED VERIFIED SKILLS
ICSR Case Processing
Quality Check
Pharmacovigilance
MedDRA Coding
Safety Database Entry
GVP
ICH Guidelines
Triage
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
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
RECOMMENDED TRAINING
1/5
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