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Sr Safety & Pv Ops Specialist

0-2 years
Not Disclosed
10 April 16, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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:

Senior Safety & PV Operations Specialist

Company:

Syneos Health

Updated:

April 11, 2025

Location:

Gurugram, India (Hybrid)

Job ID:

25001808-IND002


About Syneos Health

Syneos Health® is a global, integrated biopharmaceutical solutions organization accelerating customer success. With over 29,000 employees across 110 countries, Syneos brings together clinical, medical affairs, and commercial expertise to transform modern healthcare. The company’s model centers on customer and patient needs and values agility, innovation, and a Total Self culture.


Why Work Here?

  • Career development and progression opportunities

  • Supportive, engaged leadership and team culture

  • Diversity, equity, inclusion, and belonging are core to the mission

  • Recognition and rewards programs

  • Flexible work environment


Job Responsibilities

General

  • Maintain repositories for training, finance tracking, proposals, and quality metrics

  • Develop job aids and process documentation

  • Ensure compliance with FDA/EU/ICH guidelines

  • Support revenue tracking with SPVG teams

  • Provide SPVG metrics

  • Minimal travel (up to 15%)

Quality & Compliance

  • Document support for SOP/WI development and review

  • Monitor quality metrics, ensure audit-readiness

  • Identify risks and liaise with Corporate Quality Assurance

  • Support resolution of quality issues

Training

  • Design and deliver SPVG training programs and materials

  • Oversee LMS for Safety and Pharmacovigilance

  • Develop PV-specific modules for accreditation

Technology

  • Support audits and system demos

  • Participate in validation, testing, and documentation of Safety Systems

  • Maintain and configure Argus Safety database

  • Develop custom reports and manage data migrations

  • Troubleshoot safety systems (Argus, ArisG, Clintrace)

  • Mentor junior specialists and conduct training

Proposals

  • Collaborate on SPVG strategies for RFPs/RFIs

  • Maintain proposal templates and budget models

  • Attend bid defense and project handover meetings

  • Track and review budget and scope for accuracy


Qualifications

  • Education:
    Bachelor’s degree in life sciences, nursing, pharmacy, computer science/technology, or equivalent

  • Experience & Skills:

    • Strong background in pharmacovigilance, safety databases, and medical terminology

    • Clinical research or pharmaceutical industry experience preferred

    • Excellent in MS Office and safety database tools (Argus, Oracle, SQL, Crystal Reports, etc.)

    • Deep knowledge of ICH/GCP/safety regulations

    • Strong communication, prioritization, and decision-making skills

    • Detail-oriented and team player

    • Willingness to travel up to 15%


Additional Info

This role may evolve with changing company needs. Reasonable accommodations are provided as required, and equivalent combinations of education/experience will be considered.