Safety & PV Ops Specialist I
Location: IND-Hyderabad
Job ID: 25000428
Updated: August 22, 2025
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.
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
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.
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%).
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.
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.
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.
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.
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.
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.
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
Apply directly through the job portal or join the Talent Network to stay connected with future opportunities.
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