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Safety & Pv Ops 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, or a related technical field, or equivalent 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

Location: IND-Hyderabad
Job ID: 25000428
Updated: August 22, 2025


Company Overview

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success by translating clinical, medical affairs, and commercial insights into impactful outcomes. We center the customer and patient in all our clinical development efforts, continuously simplifying and innovating our processes.

With 29,000 employees across 110 countries, Syneos Health fosters an inclusive and collaborative culture where work here matters everywhere.


Why Work With Us?

  • Career development and progression opportunities

  • Supportive and engaged management

  • Technical and therapeutic area training

  • Peer recognition and total rewards programs

  • Commitment to an authentic Total Self culture, promoting diversity, inclusion, and belonging


Job Summary

The Safety & PV Ops Specialist I provides operational support within the Safety & Pharmacovigilance (PV) Business Unit (BU). This role assists Safety Project delivery leads in managing trainings, documentation, system setup, and access requests. Additional responsibilities include supporting department-level tasks, process improvements, and tool development.


Key Responsibilities

General

  • Develop and maintain document repositories (e.g., training, project finance, proposals tracking, RFIs, audits/inspection lists, departmental metrics)

  • Create and update job aids and process documents

  • Maintain current knowledge of FDA/EU/ICH guidelines and PV reporting regulations

  • Support SPVG annual revenue targets and ensure timely budget recognition

  • Provide SPVG metrics as assigned

  • Perform additional tasks as required

  • Minimal travel (up to 15%)

Quality & Compliance

  • Support quality planning with controlled document management

  • Facilitate quality compliance and quality control activities

  • Identify and communicate risk areas in quality assurance

  • Liaise with management and Corporate Quality Assurance (CQA) to resolve open quality issues

  • Maintain audit and inspection readiness

Training

  • Develop, track, and present training materials for Safety and PV BU

  • Collaborate with leadership to update training content

  • Oversee the Learning Management System (LMS) for Safety & PV

  • Develop PV-specific training for accreditation programs

Technology

  • Participate in audits, system demos, and validation/implementation of Safety Systems projects

  • Develop and maintain SOPs and Work Instructions (WIs) for Safety Systems

  • Administer the Argus Safety database and related project-specific configurations

  • Maintain and troubleshoot Safety systems, including Argus, ArisG, Clintrace, and sponsor databases

  • Support creation and maintenance of Safety reporting tools (e.g., Business Objects)

  • Train and mentor junior Safety Application Specialists

  • Participate in Safety System data migrations and custom report development

  • Generate and quality-check reports and listings for internal, client, or regulatory use

  • Represent Safety Applications team in project and client meetings

  • Maintain compliance with regulations and internal procedures

Proposals

  • Support SPVG gross profit targets and understand budget drivers

  • Participate in proposal strategy development and Plan Activation Strategy calls

  • Ensure accurate budget, scope, and text for RFP/RFI responses

  • Liaise with Contracts, Project Managers, and Safety teams on scope and budget changes

  • Maintain proposal templates and costing model elements

  • Attend bid defense and project handover meetings as needed


Qualifications

  • Bachelor’s degree in life sciences, nursing, pharmacy, computer science, or a related technical field, or equivalent experience

  • Knowledge of Safety Database systems and moderate medical terminology required

  • Experience in clinical research, data collection, or computer systems in pharmaceutical/CRO industry preferred

  • Proficiency with relational databases (Oracle Insight/Analytics/Data Mart, Crystal Reports/Business Objects, SQL Plus preferred)

  • Strong knowledge of ICH guidelines and safety/pharmacovigilance regulations

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

  • Excellent communication, presentation, interpersonal, organizational, and documentation skills

  • Ability to work independently and collaboratively in teams

  • Strong multitasking and prioritization abilities

  • Detail-oriented with high accuracy and deadline management

  • Effective decision-making skills

  • Minimal travel required


Additional Information

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

  • Equivalent experience, skills, or education may be considered

  • No employment contract is created by this job description

  • Compliant with applicable employment laws and diversity policies

  • Reasonable accommodations provided per ADA guidelines


About Syneos Health

  • Over 5 years, collaborated on 94% of novel FDA approved drugs and 95% of EMA authorized products

  • Involved in over 200 studies, 73,000 sites, and 675,000+ trial patients

  • Encourages initiative, innovation, and challenging the status quo

Learn more: syneoshealth.com


Application Information

  • Apply for this job or join the Talent Network to receive updates on career opportunities

  • Syneos Health values diversity and encourages applicants with transferable skills