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Safety & Pv Ops Specialist I

2+ years
Not Disclosed
10 Sept. 1, 2025
Job Description
Job Type: Hybrid Education: Bachelorโ€™s degree in Life Sciences, Nursing, Pharmacy, Computer Science, or a related field 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:

Pune, India – Hybrid


๐Ÿ†” Job ID:

25000428
Last Updated: August 22, 2025


๐Ÿข About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating customer success. Our global team transforms clinical, medical affairs, and commercial insights into actionable outcomes that impact patient lives.

With 29,000 employees across 110 countries, we offer a collaborative, fast-paced environment focused on innovative problem-solving and streamlined delivery of therapies.

๐ŸŒ Learn more: syneoshealth.com


๐ŸŒŸ Why Join Us?

  • Career Growth & Development: Clear pathways and ongoing training

  • Supportive Culture: Inclusive, collaborative, and authentic work environment

  • Recognition & Rewards: Total rewards program & peer recognition

  • Diversity & Inclusion: We celebrate diverse thoughts, backgrounds & cultures

  • Total Self Culture: Be your true self at work

WORK HERE MATTERS EVERYWHERE.


๐Ÿ“‹ Job Summary

As a Safety & PV Ops Specialist I, you will support various operational functions across the Safety & Pharmacovigilance (PVG) Business Unit. This includes project documentation, system configuration, training coordination, quality assurance, and proposal development, helping ensure operational excellence and regulatory compliance.


๐Ÿ› ๏ธ Key Responsibilities


๐Ÿ”น General Operations

  • Maintain centralized repositories for training materials, financials, proposals, RFIs, audit lists, and metrics

  • Create and update process documents, job aids, and supporting documentation

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

  • Support SPVG revenue targets and accurate recognition in RBB

  • Provide operational metrics at scheduled intervals

  • Perform other assigned tasks as needed

  • Travel: Up to 15%


๐Ÿงช Quality & Compliance

  • Support document control processes for quality planning and audits

  • Develop and communicate quality metrics

  • Perform risk-based assessments and report potential issues

  • Liaise with internal QA and Corporate QA on open Quality Issues (QIs)

  • Ensure audit/inspection readiness of safety project teams


๐ŸŽ“ Training Coordination

  • Design and deliver planned or ad hoc training programs for the PV BU

  • Work with leadership to develop content for specialist and coordinator roles

  • Manage LMS content and track completions

  • Create PV-specific training for internal accreditation


๐Ÿ’ป Technology & Systems

  • Participate in audits and provide system demos

  • Support system validation, testing, and documentation (e.g., Argus Safety)

  • Maintain SOPs/WIs related to safety systems

  • Configure and manage project-level Argus Safety database components

  • Troubleshoot issues in Argus, ArisG, Clintrace, and sponsor systems

  • Support development of reporting tools (e.g., Business Objects, SQL)

  • Create and maintain user access and reporting forms

  • Plan and execute system migrations and custom reports

  • Train and mentor junior Safety Application Specialists

  • Maintain system knowledge through meetings, workshops, and professional development


๐Ÿ’ผ Proposal & Financial Support

  • Collaborate on gross profit (GP%) targets with SPVG and project teams

  • Participate in strategy calls and develop proposal responses (RFPs/RFIs)

  • Ensure accuracy of budgets, scope, and proposal texts

  • Liaise with contracts and PMs on changes in scope or budget

  • Maintain and update costing models, templates, and SPVG proposal slides

  • Attend bid defense and handover meetings when required


โœ… Required Qualifications

๐ŸŽ“ Education

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

  • Equivalent education/experience combinations may be considered

๐Ÿง  Experience & Technical Skills

  • Experience with safety databases and medical terminology

  • Clinical research, CRO, or pharmaceutical industry background preferred

  • Proficiency in:

    • Microsoft Office Suite (Excel, Word, PowerPoint, Visio)

    • Relational databases (Oracle Insight, SQL Plus, Crystal Reports/Business Objects)

  • Strong understanding of:

    • ICH/GCP/Drug Safety regulations

    • Data entry, analysis, and quality assurance processes


๐Ÿ’ผ Core Competencies

  • Strong communication and presentation skills

  • Ability to work independently and collaboratively

  • Exceptional time management and prioritization

  • High attention to detail and documentation accuracy

  • Proactive problem-solving and decision-making abilities

  • Deadline-oriented with multitasking capability


๐ŸŒ Our Global Impact

Over the past 5 years, Syneos Health has:

  • Worked on 94% of FDA-approved novel drugs

  • Supported 95% of EMA-authorized products

  • Managed 200+ studies across 73,000+ sites and 675,000+ patients


๐Ÿ“Œ Additional Information

  • Tasks and responsibilities may change at the company’s discretion

  • Equivalent qualifications and transferable skills will be considered

  • This job description does not imply a binding employment contract

  • Syneos Health complies with all disability and equal opportunity laws

  • Reasonable accommodations provided upon request


๐Ÿ“ข How to Apply

๐Ÿ”— [Apply for this Job]

Not ready yet? [Join our Talent Network] to stay connected with future opportunities.

๐Ÿ“Œ Even if your experience doesn’t align 100%, we encourage you to apply. We value transferable skills and diverse experiences.