Instagram
youtube
Facebook

Safety & Pharmacovigilance Specialist I

1 to 2.5 years years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Hybrid Education: B.Pharm / M.Pharm / BDS / BMS / MBBS (Note: BSc / MSc not eligible) Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Safety & Pharmacovigilance Specialist I


Company

Syneos Health®
Location: Hyderabad, India (Hybrid Work Model)
Job ID: 25100800
Updated: August 20, 2025


About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success by delivering clinical, medical affairs, and commercial solutions. With a workforce of 29,000 employees across 110 countries, the company fosters innovation, collaboration, and a culture where employees can be their authentic selves.


Position Summary

The Safety & Pharmacovigilance Specialist I is responsible for processing Individual Case Safety Reports (ICSRs), ensuring quality and compliance with regulatory requirements, maintaining drug safety data, and supporting safety reporting activities. This role requires 1-2.5 years of pharmacovigilance experience and strong medical knowledge.


Key Responsibilities

  • Process ICSR cases, with emphasis on spontaneous reports.

  • Enter and track ICSR data in pharmacovigilance databases according to SOPs and safety plans.

  • Triage and evaluate ICSRs for completeness, accuracy, and regulatory reportability.

  • Code events, medical history, concomitant medications, and tests using MedDRA.

  • Compile detailed narrative summaries for ICSRs.

  • Identify missing information, raise queries, and ensure resolution.

  • Assist in timely and accurate expedited safety reporting as per regulatory requirements.

  • Maintain safety tracking for assigned projects.

  • Perform literature screening and safety reviews.

  • Maintain and update drug dictionaries and MedDRA coding.

  • Validate and submit xEVMPD product records; manually recode un-coded product and substance terms.

  • Identify and manage duplicate ICSRs.

  • Support SPOR/IDMP-related activities.

  • Conduct quality reviews of ICSRs.

  • Ensure all safety documentation is submitted to Trial Master File (TMF) and Pharmacovigilance System Master File as required.

  • Maintain compliance with SOPs, Work Instructions, GCP, ICH guidelines, and pharmacovigilance standards.

  • Foster professional relationships within project teams and external partners.

  • Participate in audits as needed.

  • Apply regulatory intelligence to safety reporting activities.


Qualifications

Education

  • B.Pharm / M.Pharm / BDS / BMS / MBBS

  • (Note: BSc / MSc not eligible)

Experience

  • 1 to 2.5 years in Pharmacovigilance (PV)

Skills & Requirements

  • Mandatory experience in spontaneous ICSR case processing

  • Strong English communication skills (written and verbal)

  • Good medical knowledge and understanding of medical terminology

  • Proficiency in safety databases and pharmacovigilance tools


Employment Details

  • Location: Hyderabad (Office-based, Hybrid work model)

  • Job Type: Full-time


Why Syneos Health?

  • Commitment to employee development, training, and career progression

  • Inclusive culture promoting authenticity and diversity

  • Collaborative and innovative work environment

  • Engagement in cutting-edge biopharmaceutical projects worldwide


Additional Information

  • Job duties are subject to change at the company’s discretion.

  • Equivalent education or experience may be considered.

  • The company complies with all relevant labor laws and promotes equal opportunity employment.

  • Reasonable accommodations available for employees with disabilities.


Application

Candidates interested in this role can apply directly or join the Syneos Health Talent Network for future opportunities.

Learn more: Syneos Health Website