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.
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