Job Title:
Safety PV Specialist II / Principal PV Specialist
Location: Mumbai, India (Preferred)
Contract Duration: 11 Months
Start Date: Immediate Joiners Preferred
Job Type: Contract
Department: Pharmacovigilance (PV) / Drug Safety
Company Overview – Syneos Health®
Syneos Health is a fully integrated biopharmaceutical solutions organization that supports customers across the clinical, medical affairs, and commercial sectors. With over 29,000 employees in 110 countries, the company accelerates the delivery of therapies through innovation and collaboration.
“Work Here Matters Everywhere”
Syneos Health fosters a Total Self culture encouraging authentic self-expression and continuous personal and professional development.
Why Join Syneos Health?
94% involvement in FDA-approved novel drugs over the past 5 years
Extensive work with EMA-authorized products
Access to industry-leading tools and training
Inclusive, diverse, and growth-focused environment
Role Summary
The Safety PV Specialist II / Principal PV Specialist supports pharmacovigilance activities including individual case safety reports (ICSRs), literature screening, periodic safety reporting, safety data reconciliation, and regulatory compliance under global and local PV standards.
Key Responsibilities
Case Management & Safety Reporting
Support the collection, processing, and reporting of Adverse Drug Reactions (ADRs) and Adverse Events (AEs)
Ensure compliance with SOPs and local/global PV requirements
Perform data cleaning and validation for safety-related data (xEVMPD, IDMP, SPOR, etc.)
Conduct MedDRA and drug coding activities
Periodic Safety Reporting
Assist in the planning, preparation, and submission of Periodic Safety Reports (PSRs)
Collaborate with Regulatory Affairs (RA) and Global Patient Safety & Pharmacovigilance (PSPV) on PSR timelines
Maintain and update the Master Planning Table and Affiliate Tracking Table (ATT)
Program Oversight
Patient Program (PP) & Managed Access Program (MAP) Management:
Validate documents for program approval
Conduct PV vendor training and regular refresher sessions
Perform monthly QC reviews and audits of PP/MAP vendor activities
Due Diligence & Agreements
Participate in due diligence and integration processes for product in-licensing and acquisitions
Ensure Safety Data Exchange Agreements (SDEAs) are in place, locally implemented, and aligned with global standards
Validate contracts, purchase orders, and service agreements for PV clauses
Training & Awareness
Conduct PV induction, awareness, and refresher trainings
Maintain updated records in MyAlliance and manage training schedules
Regulatory Support
Respond to local Health Authority safety inquiries promptly and escalate as necessary
Manage local PV alerts in collaboration with medical directors and GPE
Assist with product recalls and alert communications
Maintain the Local Pharmacovigilance System File (LPSF) per regulatory and internal requirements
Essential Qualifications
Experience
Minimum 4 years of relevant pharmacovigilance/safety experience
Prior experience in handling PSRs, ICSRs, and safety compliance documentation
Familiarity with global and local PV regulations and guidelines
Skills
Strong understanding of Good Pharmacovigilance Practices (GVP), GCP, and regulatory standards
Working knowledge of MedDRA, drug dictionaries, and PV databases
Detail-oriented with strong organizational and time-management skills
Excellent written and verbal communication skills
Preferred Qualifications
Based in or willing to relocate to Mumbai
Ability to join immediately
Experience in product integrations, PP/MAP management, and safety audits
Additional Information
The tasks and responsibilities listed are not exhaustive and may be modified at the company’s discretion.
The role adheres to Syneos Health’s global and local compliance, privacy, and inclusion standards, including adherence to the EU Equality Directive and the Americans with Disabilities Act (ADA).
How to Apply
Apply via: www.syneoshealth.com
Explore other roles or join our Talent Network for future opportunities.
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