Company: Syneos Health
Job Title: Safety and PV Ops Specialist II
Job Location: India (Remote Work Opportunity)
Job Type: Full-Time
Experience Required: Minimum 3+ Years of Pharmacovigilance Experience
Freshers Eligible: No
Job Requisition ID: 25106886
About the Company
Syneos Health is one of the world’s leading biopharmaceutical and clinical research organizations (CROs), supporting global pharmaceutical, biotechnology, and healthcare innovators throughout the drug development lifecycle. The company is recognized for its expertise in clinical development, pharmacovigilance operations, medical affairs, and regulatory services across international markets.
With operations spanning multiple countries and partnerships involving a majority of recently approved FDA and EMA products, Syneos Health continues to be a preferred employer for professionals seeking long-term growth in Pharmacovigilance and Drug Safety.
Job Overview
The Safety and PV Ops Specialist II role is designed for experienced Pharmacovigilance professionals with expertise in safety operations, quality compliance, technical documentation, safety databases, reporting systems, and PV process management.
The selected candidate will support global Safety & Pharmacovigilance operations while collaborating with cross-functional teams involved in quality management, training, safety systems, proposals, compliance activities, and operational excellence initiatives.
This remote Pharmacovigilance job in India offers exposure to global safety projects, regulatory environments, and advanced PV systems.
Key Responsibilities
Pharmacovigilance Operations
Maintain repositories of Pharmacovigilance documentation including SOPs, project finance records, audit documentation, proposal tracking systems, and departmental metrics
Develop and update job aids, process documents, workflow materials, and operational guidance documents
Ensure compliance with internal SOPs, global PV regulations, FDA guidelines, EU regulations, and ICH standards
Support operational teams with revenue tracking, forecasting, and business reporting activities
Assist with executive-level project review preparation and monthly PV operational reporting
Generate metrics reports and maintain operational performance documentation
Quality Assurance & Compliance
Support quality planning activities including controlled documentation review and revision processes
Assist in quality control verification and compliance monitoring activities
Identify operational risks and support corrective and preventive action (CAPA) management
Participate in root cause analysis investigations for quality deviations
Contribute to audit readiness and inspection preparedness activities for PV projects
Track and analyze quality metrics for Safety & Pharmacovigilance business operations
Training & Learning Management
Create and maintain Pharmacovigilance training materials for operational teams
Coordinate with leadership teams for training updates and content development
Provide Learning Management System (LMS) support for PV teams
Track employee training records and departmental compliance activities
Safety Database & Technology Support
Assist in safety database administration and maintenance activities
Support user account setup, database configuration, system upgrades, and dictionary updates
Perform validation and qualification testing for database enhancements
Generate listings, reports, and queries from safety databases for internal and regulatory use
Support safety data migration and database compliance activities
Assist with maintenance of SharePoint and other PV operational applications
Proposal & Business Support
Support proposal strategy discussions and business development activities
Assist with Request for Proposal (RFP) and Request for Information (RFI) responses
Prepare proposal templates, budget models, costing support documents, and operational presentations
Contribute to forecasting and gross profit percentage analysis activities
Support change order management and proposal documentation processes
Required Skills & Qualifications
Educational Qualification
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Clinical Research, or related healthcare field
Experience Required
Minimum 3+ years of experience in Pharmacovigilance Operations or Drug Safety
Freshers are not eligible for this role
Technical Skills
Strong expertise in Pharmacovigilance technical writing
Good understanding of global PV regulations including FDA, EMA, and ICH guidelines
Experience with safety databases and Pharmacovigilance systems
Hands-on experience with PDF tools, Microsoft PowerPoint, Excel, SharePoint, and Office applications
Knowledge of quality management systems and compliance documentation
Soft Skills
Excellent written and verbal communication skills
Strong organizational and analytical abilities
Ability to manage multiple operational tasks in a remote work environment
Cross-functional collaboration and stakeholder management skills
Why Join Syneos Health?
Opportunity to work remotely on global Pharmacovigilance projects
Exposure to international regulatory and drug safety environments
Career growth in advanced Pharmacovigilance operations and compliance
Collaborative work culture focused on innovation and healthcare impact
Work with one of the most recognized CROs in the global pharmaceutical industry
Important Note for Candidates
This position is suitable for experienced Pharmacovigilance professionals with prior exposure to PV operations, quality compliance, safety systems, and technical documentation. Candidates looking for remote Pharmacovigilance jobs in India with global exposure may find this role highly valuable for career advancement.
Apply for More Global Pharmacovigilance Jobs
Explore more latest Pharmacovigilance, Drug Safety, Clinical Research, Regulatory Affairs, and Medical Writing jobs at ThePharmaDaily.com — one of India’s rapidly growing global pharma career platforms.
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