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Safety & Pv Ops Specialist I

2+ years
Not Disclosed
10 Sept. 1, 2025
Job Description
Job Type: Hybrid Education: None 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

๐Ÿงช Job Title

Safety & PV Ops Specialist I


๐Ÿ“ Location

Hyderabad, India – Hybrid


๐Ÿ†” Job ID

25000428
Posted Date: August 22, 2025


๐Ÿข About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success. We bring clinical, medical affairs, and commercial capabilities together with a focus on real-world results.

Our global team of 29,000 employees across 110 countries is passionate about transforming life sciences by placing the customer and the patient at the center of everything we do.

๐ŸŒ Learn more: syneoshealth.com


๐Ÿ’ก Why Join Us?

  • Career development & clear growth opportunities

  • Supportive leadership and team culture

  • Recognition programs and total rewards

  • Technical & therapeutic training

  • Total Self Culture: Be your authentic self in an inclusive, diverse environment

WORK HERE MATTERS EVERYWHERE.


๐Ÿ“‹ Job Summary

You will provide operational support across multiple areas of the Safety & Pharmacovigilance (PV) Business Unit (BU). This includes assisting delivery leads with training, documentation, systems setup, and access requests. You'll also be involved in department-wide process improvement initiatives and tools development.


๐Ÿ› ๏ธ Key Responsibilities

๐Ÿ”น General

  • Maintain repositories for training, finance, RFI library, and project metrics

  • Create and update process documents and job aids

  • Stay current on FDA/EU/ICH PV reporting regulations

  • Support revenue recognition in collaboration with PMs and SPVG teams

  • Generate SPVG metrics periodically

  • Perform other duties as assigned

  • Up to 15% travel may be required


๐Ÿ” Quality & Compliance

  • Support quality planning through controlled document management

  • Perform and track quality control activities and compliance metrics

  • Identify risks via process assessments and coordinate with Corporate Quality Assurance (CQA)

  • Ensure audit and inspection readiness across safety project teams


๐ŸŽ“ Training

  • Create, present, and track training materials for the PV BU

  • Coordinate with leadership to update training content

  • Provide oversight of Learning Management System (LMS)

  • Develop PV-specific modules for internal accreditation programs


๐Ÿ–ฅ๏ธ Technology & Systems

  • Participate in audits and provide system demos

  • Support Safety System validation, documentation, testing, and SOP/WI updates

  • Administer and maintain Argus Safety database per project

  • Develop and maintain safety reporting tools (e.g., Business Objects)

  • Configure Argus components (products, users, reports, etc.)

  • Troubleshoot Argus, ArisG, Clintrace, and other sponsor databases

  • Train and mentor junior application specialists

  • Plan and execute data migrations and reporting projects

  • Maintain regulatory compliance (GCP, ICH, SOPs, WIs)

  • Represent Safety Applications in client and project meetings


๐Ÿ“‘ Proposals & Business Support

  • Contribute to SPVG gross profit targets through budgeting support

  • Attend activation calls and collaborate on proposal strategy

  • Draft accurate proposal content, scope, and budgets for RFPs/RFIs

  • Coordinate with contracts and project managers on scope changes

  • Maintain proposal templates, costing models, and SPVG slides

  • Support bid defenses and project handovers as needed


โœ… Qualifications

๐ŸŽ“ Education & Experience

  • Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Computer Science, or related field

  • Equivalent experience may be considered

  • Strong exposure to clinical research, PV operations, or CRO environments preferred

๐Ÿง  Technical Skills

  • Experience with safety databases (e.g., Argus, ArisG) and medical terminology

  • Knowledge of ICH guidelines, GCP, FDA/EU PV regulations

  • Proficient in relational databases (Oracle Insight, Data Mart, SQL, Crystal Reports, Business Objects)

  • Advanced MS Office skills (Excel, Word, Visio, PowerPoint, Outlook)

๐Ÿงฉ Core Competencies

  • Strong communication (written & verbal)

  • Analytical and documentation skills

  • Ability to prioritize and multitask across multiple projects

  • Decision-making and problem-solving mindset

  • Detail-oriented and deadline-focused

  • Team player and independent contributor


๐Ÿ“ Additional Information

  • Duties may evolve based on business needs

  • The company may determine role equivalency based on experience

  • This is not an employment contract

  • Reasonable accommodations available per the Americans with Disabilities Act (ADA)

  • Syneos Health promotes equal opportunity and inclusion across all regions


๐ŸŒŸ About Our Impact

In the last 5 years, Syneos Health has:

  • Worked on 94% of novel FDA-approved drugs

  • Supported 95% of EMA-authorized products

  • Participated in 200+ studies across 73,000+ sites involving 675,000+ trial patients

We challenge the status quo every day—and invite you to do the same.


๐Ÿ“Œ Application Details

If you’re ready to make a difference in global health, [Apply for this job now].
Not ready yet? [Join our Talent Network] to stay connected for future opportunities.

๐Ÿ”— Encouraged to apply even if your experience doesn’t fully match the job description—we value transferable skills.