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Safety & Pv Ops Specialist I

2+ years
Not Disclosed
10 Aug. 29, 2025
Job Description
Job Type: Remote Education: Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Computer Science, Technology 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, accelerating customer success by translating clinical, medical affairs, and commercial insights into outcomes. Our patient-centric Clinical Development model continuously simplifies and streamlines processes to make Syneos Health both easier to work with and for.

With 29,000 employees across 110 countries, we foster a culture where WORK HERE MATTERS EVERYWHERE.


Why Syneos Health?

  • Strong focus on career development and progression

  • Supportive and engaged management

  • Technical and therapeutic area training

  • Peer recognition and total rewards program

  • Commitment to Total Self culture for authentic self-expression

  • Emphasis on diversity, inclusion, and belonging


Job Summary

Provides operational support across multiple areas within the Safety & Pharmacovigilance (PV) Business Unit (BU). Assists Safety Project delivery leads with tasks such as training management, document filing and updates, system setup, and access requests. Supports department-level tasks, process improvement initiatives, and tool development.


Key Responsibilities

General

  • Develop and maintain repositories for relevant documents (training materials, project finance, proposals, RFI library, audits/inspections, metrics).

  • Create and maintain job aids, process documents, and supporting documentation.

  • Stay current with FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.

  • Support SPVG Annual Revenue targets through collaboration with operational teams and Therapeutic BU PMs/Project Directors.

  • Provide SPVG metrics at agreed intervals.

  • Perform other related duties as assigned.

  • Travel: Minimal (up to 15%).

Quality & Compliance

  • Facilitate quality planning by providing document control and supporting department/client-specific documents.

  • Track and communicate quality metrics to assess team and individual performance.

  • Support quality compliance verification and quality control activities.

  • Identify and communicate risks through risk-based process assessments.

  • Liaise with management and Corporate Quality Assurance to resolve open Quality Issues (QIs).

  • Help maintain audit and inspection readiness for safety project teams.

Training

  • Plan, develop, create, track, and deliver training materials for Safety and PV BU (e.g., Safety Specialist training, revenue recognition).

  • Liaise with Safety and PV leadership to identify training content needs.

  • Oversee Learning Management System (LMS) for Safety and PV.

  • Develop PV-specific training for accreditation programs.

Technology

  • Participate in audits and system demonstrations as needed.

  • Assist in Safety Systems implementation, validation, testing, and documentation.

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

  • Understand IT SOPs/WIs impacting Safety business processes.

  • Analyze and assist with internal/external regulatory or customer reporting needs from Safety Systems.

  • Implement process efficiencies related to Safety and PV.

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

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

  • Manage Argus Project Information, Product/Licenses, User Access, and Report Request forms.

  • Troubleshoot Argus and other Safety systems issues.

  • Develop training materials for Safety Systems end-users and trainers.

  • Mentor junior Safety Application Specialists.

  • Advise users on alternate sponsor databases (ArisG, Clintrace, Sponsor Argus).

  • Ensure compliance with SOPs, regulations, GCP, ICH guidelines, and drug development processes.

  • Plan, write, and execute Safety System data migrations and custom reports.

  • Generate and quality-check reports from Safety databases for internal, client, or regulatory use.

  • Represent Safety Applications team in project and client meetings.

  • Maintain expertise through internal meetings and professional development.

Proposals

  • Support SPVG Annual Gross Profit (GP%) targets by working with operational teams.

  • Participate in Plan Activation Strategy calls and develop Safety and PVG proposal strategies.

  • Ensure accuracy of SPVG budget, scope, and text in RFPs/RFIs by collaborating with SPVG and corporate partners.

  • Solicit input and liaise with leadership for proposal team selection.

  • Manage scope and budget changes by coordinating with Contracts and Project Managers.

  • Develop and maintain proposal templates and slides, periodically reviewing updates.

  • Maintain SPVG costing model elements and review project budgets for accuracy.

  • Attend bid defense and project hand-over meetings as needed.


Qualifications

  • Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Computer Science, Technology, or equivalent experience.

  • Experience with Safety Database systems and moderate medical terminology required.

  • Preferred: Experience in clinical research, data collection, or pharmaceutical/CRO industry.

  • Strong computer skills and relational database knowledge (Oracle Insight/Analytics, Crystal Reports/Business Objects, SQL Plus preferred).

  • Excellent knowledge of ICH guidelines and safety/pharmacovigilance regulations.

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

  • Ability to work independently and collaboratively.

  • Strong multitasking, prioritization, and organizational skills.

  • Excellent written and verbal communication, presentation, and interpersonal skills.

  • Detail-oriented with high accuracy and ability to meet deadlines.

  • Decision-making ability and managing multiple priorities.

  • Minimal travel required.


Additional Information

  • The list of duties is not exhaustive; the company may assign additional responsibilities as needed.

  • Equivalent education/experience considered.

  • Employment is at will; no contract implied.

  • Compliant with local legislation, including EU Equality Directive and Americans with Disabilities Act.

  • Reasonable accommodations available for qualified individuals.


About Syneos Health

  • Collaborated with 94% of Novel FDA Approved Drugs, 95% of EMA Authorized Products over past 5 years.

  • Supported 200+ studies, 73,000+ sites, and 675,000+ trial patients worldwide.

  • Encourages initiative and innovation in a dynamic environment.

Learn more: www.syneoshealth.com


How to Apply

  • Apply directly through the job portal or join the Talent Network to stay connected with future opportunities.