Location: IND-Hyderabad-Hybrid
Job ID: 25000428
Updated: August 22, 2025
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success by translating clinical, medical affairs, and commercial insights into impactful outcomes. Our Clinical Development model centers on the customer and patient, emphasizing simplification and streamlined processes to improve collaboration and therapy delivery worldwide.
Commitment to career development, progression, and supportive management.
Robust technical and therapeutic training programs.
Inclusive Total Self culture, fostering authenticity and belonging.
Diverse global workforce of 29,000 employees across 110 countries.
Passionate, agile teams driven to innovate and improve patient lives.
Provide operational support across multiple areas within the Safety & Pharmacovigilance Business Unit (BU). Support Safety Project delivery leads in tasks such as training management, document filing and updates, systems setup, and access requests. Assist with department-level activities, process improvements, and tool development as needed.
Develop and maintain repositories for documents (training, finance, proposals, audit logs, metrics).
Create and update job aids, process documents, and supporting materials.
Maintain knowledge of FDA, EU, and ICH guidelines related to safety and pharmacovigilance reporting.
Facilitate SPVG annual revenue targets by collaborating with operational teams and project managers to ensure timely budget recognition.
Provide SPVG metrics and perform additional tasks as assigned.
Travel up to 15% may be required.
Support quality planning by managing controlled documents and tracking quality metrics.
Facilitate quality compliance and control activities.
Identify and communicate risk areas via risk-based assessments.
Liaise with Corporate Quality Assurance (CQA) to resolve open Quality Issues (QIs).
Support audit and inspection readiness for safety project teams.
Plan, develop, and deliver training materials for Safety & Pharmacovigilance BU, including new or updated content.
Oversee Learning Management System (LMS) for Safety & Pharmacovigilance.
Develop PV-specific training modules for accreditation programs.
Participate in audits and system demos.
Assist with implementation, validation, and testing of Safety Systems projects.
Develop and maintain SOPs and Work Instructions related to Safety Systems.
Understand IT SOPs/WIs impacting Safety Systems business processes.
Analyze and assist with regulatory/customer report programs from Safety Systems.
Implement process efficiencies related to Safety and Pharmacovigilance.
Configure, administer, and maintain Argus Safety database per project to meet sponsor requirements.
Develop, test, and maintain Safety reporting tools (e.g., Business Objects).
Maintain Argus project info, licenses, user access, and report request forms.
Troubleshoot Argus and other safety system issues.
Develop training materials and mentor junior Safety Application Specialists.
Advise users on alternate sponsor databases (ArisG, Clintrace, Sponsor Argus).
Ensure compliance with global regulations, SOPs, and guidelines (GCP, ICH).
Participate in Safety System data migrations and custom report creation.
Generate and quality check reports/listings/queries for internal, client, or regulatory use.
Represent Safety Applications team in project and client meetings.
Maintain expertise via internal meetings and professional development.
Support SPVG Gross Profit percentage targets by collaborating with operational teams.
Participate in Plan Activation Strategy calls and proposal strategy development.
Ensure accuracy of SPVG budgets, scope, and texts in RFPs/RFIs by working with internal partners.
Liaise with Contracts, Project Managers, and Safety Project Managers for scope/budget changes.
Maintain and update proposal templates and SPVG slides.
Review costing models against actual project financials for accuracy.
Attend bid defense and project hand-over meetings as required.
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Computer Science, Technology, or equivalent experience.
Experience with Safety Database systems and moderate medical terminology.
Preferred: Experience in clinical research, data collection, or pharmaceutical/CRO industry.
Strong computer skills, knowledge of relational databases; Oracle Insight/Analytics/Data Mart, Crystal Reports/Business Objects, SQL Plus preferred.
Excellent knowledge of ICH guidelines and safety/pharmacovigilance regulations.
Proficiency in Microsoft Office (Word, Excel, Visio, PowerPoint), Outlook, and internet.
Ability to work independently and collaboratively in a team.
Strong multitasking, prioritization, and organizational skills.
Excellent communication (written and verbal) and presentation skills.
Detail-oriented, accurate, and deadline-driven.
Able to make effective decisions and manage multiple priorities.
Minimal travel may be required.
The list of duties is not exhaustive; additional responsibilities may be assigned.
Equivalent skills and experience will be considered.
No employment contract implied.
Compliance with local legislation and diversity/inclusion policies.
Reasonable accommodations available under the Americans with Disabilities Act.
Worked with 94% of novel FDA-approved drugs and 95% of EMA-authorized products in the past 5 years.
Involved in 200+ studies across 73,000 sites and over 675,000 trial patients.
Encourages innovation, initiative, and challenges to the status quo.
Not ready to apply? Join our Talent Network to stay connected with future opportunities.
Learn more: Syneos Health Website
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