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Safety & Pharmacovigilance (Pv) Operations Specialist I

2+ years
Not Disclosed
10 Sept. 1, 2025
Job Description
Job Type: Full Time Education: Bachelor’s degree in life sciences, nursing, pharmacy, computer science, technology, or equivalent 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 & Pharmacovigilance (PV) Operations Specialist I

📍 Location

India – Pune

🆔 Job ID

25000428

📅 Updated

August 22, 2025


🌐 Company Overview: Syneos Health®

Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We convert unique clinical, medical affairs, and commercial insights into outcomes addressing modern market challenges.

Our Clinical Development model centers on the customer and patient, continuously simplifying and streamlining processes for operational excellence. Join a global team of passionate problem solvers dedicated to delivering life-changing therapies.

Global Impact: 29,000 employees across 110 countries
Experience: Supported 94% of novel FDA-approved drugs and 95% of EMA-authorized products over the past 5 years.


💼 Role Summary

As a Safety & PV Ops Specialist I, you will provide operational support across multiple areas within the Safety & Pharmacovigilance Business Unit (BU). You will assist project delivery leads with training management, document filing, system setup, and access requests. You will also contribute to department-level tasks, process improvements, and tool development.


🔑 Key Responsibilities

General

  • Develop and maintain repositories for key documents (training materials, project finance, proposals, audits, metrics).

  • Maintain job aids, process documents, and supporting documentation.

  • Stay updated on FDA/EU/ICH guidelines related to safety and pharmacovigilance reporting.

  • Support SPVG Annual Revenue targets through collaboration with operational teams and project managers.

  • Provide SPVG metrics as required.

  • Perform additional duties as assigned.

  • Minimal travel (up to 15%).

Quality & Compliance

  • Support quality planning by managing controlled documents and quality metrics.

  • Facilitate quality compliance and quality control activities.

  • Assist quality assurance by identifying risks and liaising with Corporate Quality Assurance (CQA).

  • Maintain audit and inspection readiness for safety projects.

Training

  • Plan, develop, track, and present training materials for Safety and Pharmacovigilance BU.

  • Manage Learning Management System (LMS) oversight.

  • Develop PV-specific training for accreditation programs.

Technology

  • Participate in audits, system demos, and Safety Systems validation projects.

  • Develop and maintain SOPs and Work Instructions related to Safety Systems.

  • Analyze and support regulatory report needs from Safety Systems.

  • Configure, administer, and maintain Argus Safety database per project requirements.

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

  • Create and manage Argus project documentation and user access.

  • Troubleshoot Safety system issues and provide user support.

  • Train and mentor junior Safety Application Specialists.

  • Assist with alternate sponsor databases (e.g., ArisG, Clintrace).

  • Maintain compliance with SOPs, regulations, and guidelines.

  • Support data migrations, custom report generation, and quality checks.

  • Represent Safety Applications team in meetings.

Proposals

  • Support SPVG Annual Gross Profit targets by working with operational teams.

  • Contribute to Safety and PVG proposal strategy and development.

  • Ensure accuracy of budgets, scopes, and proposal content.

  • Assist with contract scope/budget changes.

  • Maintain proposal templates and costing models.

  • Participate in bid defense and project hand-over meetings.


🎓 Qualifications

Criteria Details
Education Bachelor’s degree in life sciences, nursing, pharmacy, computer science, technology, or equivalent
Experience Knowledge of Safety Database systems and medical terminology
Industry Experience Clinical research, data collection, or CRO/pharmaceutical experience preferred
Technical Skills Proficiency in relational databases, Oracle Insight/Analytics, Business Objects, SQL preferred
Regulatory Knowledge Strong understanding of ICH guidelines and safety/pharmacovigilance regulations
Software Skills Microsoft Office Suite, Outlook, internet
Other Skills Strong organizational, communication, presentation, and documentation skills
Work Style Ability to work independently and in teams, multitask, meet deadlines, make effective decisions
Travel Minimal travel may be required

🌟 Why Syneos Health?

  • Focus on career development with training and progression opportunities

  • Supportive leadership and peer recognition programs

  • Inclusive “Total Self” culture fostering authenticity and belonging

  • Work on impactful projects within a global and agile environment


⚠️ Additional Information

  • Job responsibilities may change at the company’s discretion.

  • Equivalent experience, skills, and education may be considered.

  • The company complies with all applicable employment laws, including ADA and EU Equality Directive.

  • This description is not an employment contract.


🚀 How to Apply

Apply now: Syneos Health Careers
Not ready? Join our Talent Network to stay connected with future opportunities.


Syneos Health is committed to building a diverse, inclusive workplace and encourages candidates with transferable skills to apply.