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Pharmacovigilance Product And Regulatory Associate

3-4 years
₹8.5 – ₹13.5 LPA
10 July 22, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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)