Job Title:
Senior Safety & PV Operations Specialist
Company:
Syneos Health
Location:
India-Asia Pacific - Hybrid (Pune, India)
Job ID:
25001808-IND005
Job Type:
Full-Time
Role Overview:
The Senior Safety & PV Operations Specialist will play a crucial role in managing safety and pharmacovigilance (PV) operations, maintaining quality compliance, and supporting technology and training efforts in a hybrid setting. This includes overseeing safety databases, ensuring adherence to regulations, and developing proposals and training materials for safety and pharmacovigilance teams.
Key Responsibilities:
Document & Process Management:
Maintain and organize relevant documentation related to safety and PV operations.
Develop job aids, process documents, and ensure the repository of materials is updated.
Support training materials and processes for Safety and PV teams.
Quality & Compliance:
Facilitate quality planning and compliance activities, track quality metrics, and ensure project readiness for audits/inspections.
Communicate and address any risks, non-compliance, and provide expertise in quality assurance activities.
Training Development:
Design, track, and present training materials for Safety and Pharmacovigilance teams.
Oversee the Learning Management System (LMS) for Safety and PV.
Develop PV-specific training programs for internal accreditation.
Technology & Safety Systems:
Participate in audits, system demos, and the validation of Safety Systems like Argus.
Configure, maintain, and troubleshoot Safety databases to meet sponsor requirements.
Create and maintain safety-related reporting tools and documentation.
Proposals & Budgeting:
Support Safety and PV proposal development, ensuring the correct scope, budget, and team members.
Liaise with leadership to align on project scopes, budgets, and accurate proposals for RFPs and RFIs.
Assist in tracking project financials and maintaining proposal templates.
Requirements:
Education:
Bachelor’s degree in life sciences, pharmacy, computer science, or related fields (technical role) or equivalent experience.
Experience:
Extensive experience in clinical research, safety, and pharmacovigilance with an understanding of industry standards, ICH guidelines, and safety database systems (e.g., Argus, Oracle Insight).
Proficiency in Microsoft Office Suite and safety-specific software tools.
Skills:
Strong organizational, communication, and documentation skills.
Knowledge of global safety and pharmacovigilance regulations, ICH guidelines, and regulatory reporting requirements.
Ability to manage multiple priorities in a fast-paced environment.
Ability to work independently and as part of a team.
Why Syneos Health?
Employee Development: Syneos Health promotes career growth, training, and peer recognition, fostering a culture where employees can thrive and progress.
Inclusive Culture: The company values diverse perspectives and promotes a "Total Self" culture, where employees can be their authentic selves.
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