Cognizant, a global leader in professional services, is seeking a TM-Pharmacovigilance professional to join our team in Mumbai. This role is critical in ensuring drug safety, regulatory compliance, and patient well-being through advanced pharmacovigilance practices.
Key Responsibilities:
✔ Monitor and analyze adverse drug reactions (ADRs) to ensure patient safety.
✔ Collaborate with teams to gather regulatory intelligence and ensure compliance.
✔ Prepare and submit regulatory reports in line with global standards.
✔ Develop risk management strategies to enhance drug safety.
✔ Support research & development (R&D) in pharmacovigilance methodologies.
✔ Maintain up-to-date knowledge of industry trends and regulatory changes.
Qualifications & Skills:
✅ B.Pharm/M.Pharm with Certified Pharmacovigilance Professional (CPP) or Regulatory Affairs Certification.
✅ Strong expertise in pharmacovigilance, regulatory intelligence, and compliance.
✅ Excellent English communication (written & verbal).
✅ Experience in regulatory affairs & R&D (preferred).
✅ Ability to work in rotational shifts (hybrid model).
While Pharmacovigilance (PV) and Regulatory Affairs (RA) are distinct functions, they often overlap in the pharmaceutical industry—especially in drug safety and compliance. Here’s why Cognizant may prefer (or require) a Regulatory Affairs Certification for this PV role:
1. Regulatory Intelligence Integration
- The job description mentions “regulatory intelligence” as a key responsibility.
- PV professionals must interpret global drug safety regulations (e.g., FDA, EMA, WHO) to ensure compliance.
- A Regulatory Affairs Certification ensures familiarity with ICH-GCP, GVP, and regional pharmacovigilance laws.
2. Cross-Functional Collaboration
- PV teams work closely with Regulatory Affairs to:
- Submit Periodic Safety Update Reports (PSURs).
- Address regulatory queries on adverse events.
- Align risk-management plans (RMPs) with compliance requirements.
- RA-certified candidates understand submission workflows, speeding up processes.
3. Risk Management & Compliance
- PV isn’t just about collecting ADRs—it’s about mitigating risks while meeting legal standards.
- RA training covers drug approval pathways, labeling laws, and post-marketing surveillance, which directly impact PV strategies.
4. Client & Stakeholder Expectations
- Many clients (e.g., Big Pharma) expect PV teams to speak the language of regulators.
- An RA-certified PV professional can bridge gaps between safety data and regulatory expectations, enhancing credibility.
5. Cognizant’s Consultative Approach
- As a consulting firm, Cognizant likely serves clients who want end-to-end drug safety + compliance support.
- Hiring PV specialists with RA knowledge allows them to offer integrated solutions without outsourcing separately.
Why Join Cognizant?
🔹 Global Leader: Part of NASDAQ-100 & Forbes World’s Best Employers 2024.
🔹 Inclusive Culture: Collaborative and innovative work environment.
🔹 Career Growth: Opportunities to upskill and advance in pharma & regulatory fields.
🔹 Work-Life Balance: Hybrid model with flexible shifts.
About Cognizant
Cognizant (Nasdaq: CTSH) is a Fortune 500 company empowering businesses through digital transformation. With 300,000+ professionals worldwide, we deliver cutting-edge solutions in pharmaceuticals, technology, and consulting.
