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Safety & Pv Ops Specialist I

2+ years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Remote Education: Bachelor’s degree in life sciences, nursing, pharmacy, computer science, or a related field. (Or equivalent combination of education and experience) 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 & PV Ops Specialist I


Job Details

  • Updated: August 22, 2025

  • Location: Remote – India (IND-Remote)

  • Job ID: 25000428

  • Department: Safety & Pharmacovigilance (SPVG)

  • Employment Type: Full-Time

  • Travel: Minimal (up to 15%)


About Syneos Health

Syneos Health® is a global, fully integrated biopharmaceutical solutions organization. With over 29,000 employees across 110 countries, we aim to accelerate customer success and improve patient outcomes. Our culture promotes diversity, authenticity, and continuous development through our Total Self culture and employee-focused programs.


Position Summary

The Safety & PV Ops Specialist I provides operational support to the Safety & Pharmacovigilance (SPVG) Business Unit across multiple areas including training, documentation, technology systems, compliance, quality assurance, and proposals. This role assists Safety Project Delivery Leads and contributes to process improvements, system configuration, data tracking, and SPVG proposal development.


Key Responsibilities

1. General Operations

  • Maintain SPVG documentation repositories (training records, finance, proposals, metrics, audits, etc.)

  • Develop and update job aids, process documents, and training materials.

  • Support revenue recognition processes and provide regular SPVG metrics.

  • Assist with additional assigned work-related tasks.


2. Quality & Compliance

  • Support controlled document development and revision processes.

  • Track and report on quality metrics.

  • Assist in identifying and resolving areas of compliance risk.

  • Liaise with Corporate Quality Assurance (CQA) for quality investigations (QIs).

  • Ensure audit and inspection readiness.


3. Training

  • Design and deliver training materials for SPVG staff (Safety Specialists, Coordinators, etc.)

  • Manage training records in the Learning Management System (LMS).

  • Support development of PV-specific content for accreditation programs.


4. Technology & Systems

  • Support validation, testing, and maintenance of safety systems (e.g., Argus).

  • Configure and administer project-specific setups in safety databases.

  • Troubleshoot technical issues with Argus and other safety platforms.

  • Assist with data migrations, reporting tools, and custom safety reports.

  • Train and mentor junior Safety Applications Specialists.

  • Maintain compliance with IT and safety systems SOPs/WIs.


5. Proposal & Business Development

  • Support proposal strategy planning by working with SPVG leadership.

  • Draft proposal content, budget, and scope of work for RFPs/RFIs.

  • Update SPVG costing models and templates.

  • Liaise with Contracts team for budget and scope changes.

  • Attend bid defense and project handover meetings as needed.


Required Qualifications

  • Bachelor’s degree in life sciences, nursing, pharmacy, computer science, or a related field.
    (Or equivalent combination of education and experience)

  • Experience with safety database systems and medical terminology.

  • Prior experience in clinical research, data management, or pharmacovigilance preferred.

  • Familiarity with FDA/EU/ICH guidelines and GCP requirements.


Technical Skills

  • Strong knowledge of relational databases, especially Argus Safety.

  • Preferred experience with:

    • Oracle Insight / Analytics / Data Mart

    • Crystal Reports / Business Objects

    • SQL Plus

  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Visio).


Soft Skills

  • Strong communication and presentation skills.

  • Excellent organizational and documentation abilities.

  • Able to prioritize multiple tasks and meet deadlines.

  • Comfortable working independently or as part of a team.

  • Decision-making and problem-solving capabilities.


Why Join Syneos Health?

  • Career development and progression programs.

  • Total rewards and peer recognition.

  • Supportive line management and leadership.

  • Inclusive culture where authenticity is valued.

  • Work with 94% of FDA novel drug approvals and 95% of EMA-authorized products.


Additional Information

  • This description may evolve based on business needs.

  • Equivalent experience or education may be considered.

  • The company complies with the Americans with Disabilities Act and provides reasonable accommodations as needed.


How to Apply

👉 Apply for this job
📌 Or join our Talent Network to stay informed on future opportunities.


Equal Opportunity Statement

Syneos Health is committed to fostering a diverse and inclusive workplace. If your experience doesn’t align perfectly with the job requirements, we still encourage you to apply.