Perform end-to-end Individual Case Safety Report (ICSR) processing across multiple sources including spontaneous reports, clinical trials, and literature.

Execute structured case workflows including intake, triage, duplicate check, data entry, MedDRA coding, narrative writing, and submission readiness.

Ensure high-quality and compliant data entry in pharmacovigilance safety databases during initial case processing phases.

Conduct medical review and assessment of adverse events including seriousness, expectedness, and causality (based on role level).

Perform follow-ups for incomplete safety data and ensure completeness of case information.

Execute quality control (QC) checks on processed cases based on experience and productivity benchmarks.

Technical & Domain Expertise

Strong understanding of pharmacovigilance lifecycle and global safety reporting requirements (ICH, GVP guidelines).

Hands-on exposure or training in ICSR processing and safety database systems (Argus, ArisG preferred).

Knowledge of MedDRA coding conventions and adverse event classification.

Familiarity with literature screening and clinical trial safety reporting workflows.

Leadership & Business Impact

Direct contribution to global patient safety by ensuring accurate adverse event reporting.

Supports regulatory compliance and audit readiness for global submissions.

Collaborates with cross-functional global teams including clinical operations and regulatory affairs.

Builds foundation for advanced PV roles such as signal detection and risk management.

Benefits & Total Rewards

Exposure to global pharmacovigilance systems and CRO environment.

Structured training and onboarding programs for early-career professionals.

Opportunities to work on multi-client international safety projects.

Inclusive workplace culture with performance-driven growth opportunities.

REQUIRED VERIFIED SKILLS

ICSR Processing

Pharmacovigilance

Drug Safety

MedDRA Coding

Narrative Writing

Clinical Trial Safety

Literature Case Processing

Regulatory Compliance

Safety Database Entry

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting

For 0–2 years candidates in CROs like Syneos Health, salaries typically range from ₹3.5–6.5 LPA depending on skill level and prior exposure. Additional benefits may include performance bonuses, shift allowances, and global project exposure, which enhances long-term earning potential.

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 role is a foundational entry into the pharmacovigilance domain within a global CRO. Professionals typically progress from Drug Safety Associate to Senior Specialist, then to roles such as Safety Scientist, Signal Detection Analyst, or Pharmacovigilance Lead. With experience, individuals can transition into risk management, aggregate reporting (PSUR/PBRER), or regulatory strategy roles, significantly expanding their influence and compensation trajectory.

APPLICATION ADVISORY

To stand out, demonstrate strong understanding of ICSR workflow and MedDRA coding. Highlight any internships, certifications (e.g., pharmacovigilance training), or hands-on exposure to Argus/ArisG. Prepare for interviews with case-based scenarios (e.g., seriousness assessment, narrative writing). Accuracy and attention to detail are heavily tested.

RECOMMENDED TRAINING

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