Pharmacovigilance Product and Regulatory Associate – Opella
Location: Hyderabad
Experience: 3 to 4 years
Job Type: Full-Time
Application Deadline: August 5, 2025
Job ID: R2804117
About the Role:
Opella is hiring a Pharmacovigilance Product and Regulatory Associate for its Hyderabad location. In this centralized role, you will work with global safety teams, regulatory partners, and internal stakeholders to manage pharmacovigilance (PV) product configurations, regulatory compliance, and safety reporting rule configurations in global PV databases. The position involves maintaining up-to-date records in systems like Veeva Vault and ensuring strict adherence to PV standards and SOPs.
Key Responsibilities:
Product & Regulatory Data Management:
Ensure accurate configuration of products, studies, and country-specific rules in global PV databases.
Maintain and update PV labeling documents in Veeva Vault and ensure access across relevant functions.
Oversee automation of labeling in PV Safety DB for CHC products.
Coordinate registration lifecycle updates, annual product reviews, and rule reviews.
Maintain product mapping sheets and truncated lists with appropriate naming.
Stakeholder Collaboration & Communication:
Work closely with Country Safety Heads (CSHs), QPPVs, SSDM, SDEA, and other stakeholders.
Track Regulatory Intelligence updates and manage communication with affiliates.
Interface with global teams to ensure consistency and compliance in PV practices.
Reporting & Compliance:
Monitor and act on Veeva Flash and Monitoring reports for product registration updates.
Ensure all processes adhere to SOPs, QDs, and global PV regulations (FDA, EMA, ICH, etc.).
Support safety reporting including CIOMS, EudraVigilance, and FDA REMS submissions.
Participate in audits, process improvements, and documentation of regulatory compliance.
Candidate Profile:
Education: Bachelor’s degree in Pharmacy, Life Sciences, or related field
Experience:
3–4 years in the pharmaceutical industry, focused on pharmacovigilance
Experience with safety databases such as ARGUS, Aris-G (LSMV), and Veeva
Familiarity with global PV regulations (FDA, EMA, ICH, GVP)
Proven expertise in case processing, product/reporting rule configuration, and SDEA management
Soft Skills:
Strong communication, stakeholder engagement, and negotiation skills
High attention to detail, project management, and problem-solving capabilities
Ability to work independently and in cross-functional global teams
Technical Skills:
Advanced Microsoft Excel, Word, and PowerPoint
Regulatory documentation and presentation skills
Understanding of adverse event classification and compliance requirements
Language: Fluent in English (written and verbal)
Why Join Opella?
As a leader in the self-care space, Opella is home to some of the world’s most trusted health brands. You’ll work with an ambitious and collaborative team driven by innovation and impact. With a strong focus on personal well-being, inclusivity, and professional development, Opella offers an ideal platform to grow your pharmacovigilance career.
Estimated Salary: ₹8.5 – ₹13.5 LPA (based on experience and role responsibility)
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