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 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.
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
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.
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%)
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
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
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
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
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
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
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
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
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