The pharmaceutical and healthcare industry offers a wide range of non-clinical career opportunities for medical, pharmacy, and life science graduates in clinical research, pharmacovigilance, medical writing and many more important and exciting fields. Among these fields, Pharmacovigilance (PV) and Regulatory Affairs (RA) stand out as two of the most promising, in-demand and evergreen fields in the pharma and healthcare industry
Both play vital roles in ensuring the safety, efficacy, and compliance of the drug, but they carry out different roles and responsibilities and demand different skill requirements. If you are exploring a transition from academics or clinical practice to a corporate pharma career, understanding these differences will help you choose the right path. In this blog, we will discuss how Pharmacovigilance is different from Regulatory affairs or Pharmacovigilance Vs Regulatory Affairs/ Drug Safety Affairs.
What is Pharmacovigilance?
Pharmacovigilance is the science of detecting, assessing, and preventing adverse effects or other drug-related problems. It ensures that medicines remain safe and effective after they reach the market.
Key Responsibilities of PV Professionals
- The most important responsibility of a PV professional is to collect and analyse adverse drug reaction (ADR) reports
- Performing case processing and medical review, and conducting signal detection and risk-benefit assessments, is also safety reports such as PSURs and RMPs
- Ensuring compliance with global drug safety regulations is the goal in Pharmacovigilance.
Top Employers:
Pharmacovigilance professionals are in high demand at pharmaceutical companies, CROs (Contract Research Organisations), and global KPOs (Knowledge Process Outsourcing) such as IQVIA, Accenture, Cognizant, and Parexel.
What is Regulatory Affairs?
Regulatory Affairs (RA) ensures that pharmaceutical products comply with national and international regulations throughout their development, manufacturing, and marketing stages.
Key Responsibilities:
- Professionals in regulatory affairs perform vital tasks of preparing and submitting regulatory documents to authorities like CDSCO, USFDA, and EMA
- They also manage product registration and licensing, and handle renewals, variations, and post-marketing compliance
- Update teams on regulatory guideline changes
- Coordinating between R&D, QA, and manufacturing departments is also one of the most important tasks performed by RA professionals, which keeps the team and other departments working in sync
Top Employers:
RA professionals work in pharma and biotech companies, medical device firms, and regulatory consultancy organisations.
Pharmacovigilance vs Regulatory Affairs: Job Roles, Salary, and Experience
Eligibility and Educational Background
Both fields are ideal for graduates from life sciences, pharmacy, medicine, or allied health backgrounds.
For Pharmacovigilance:
For Regulatory Affairs:
Which Career Should You Choose?
Pharmacovigilance is the right choice for you if:
- Your interest lies in clinical data and patient safety
- Analysing case reports and drug effects is something that you can enjoy
- Want to work in post-marketing drug safety
Regulatory Affairs, if you can be the pert suit for you if you:
- Are detail-oriented and organised
- Enjoy working with compliance, guidelines, and documentation
- Want to contribute to global drug approvals and regulatory strategy
Detailed Comparison: Pharmacovigilance vs Regulatory Affairs
| Aspects | Pharmacovigilance | Regulatory Affairs |
| Primary Responsibility | Monitoring, assessing, and reporting adverse drug reactions (ADRs) to ensure drug safety post-marketing. | Ensuring that pharmaceutical products comply with all regulations and guidelines before and after approval. |
| Core Activities | Case processing, signal detection, risk management, literature monitoring, and periodic safety reporting. | Regulatory submissions, dossier preparation, labelling compliance, product registration, and lifecycle management. |
| Objective | Protect public health by detecting and minimising risks associated with medicines. | Facilitate timely market approval and maintain compliance across global regulatory frameworks. |
| Work Environment | Office-based roles with extensive use of safety databases (e.g., Argus, ARISg, Oracle). Involves coordination with medical and clinical teams. | Collaborative environment with R&D, QA, and manufacturing teams. Heavy documentation and submission-based work. |
| Skills | Strong medical and analytical knowledge, attention to detail, and knowledge of ICH-GCP and MedDRA coding. | Excellent understanding of global regulatory guidelines (USFDA, EMA, CDSCO), documentation, and communication skills. |
| Career Growth | Progression from Drug Safety Associate → Senior PV Scientist → Team Lead → PV Manager → Director PV. | Growth path from RA Associate → Specialist → Manager → Global Regulatory Lead → Director RA. |
| Work-life balance | Generally stable with defined working hours, especially in CROs and IT-enabled service companies. | May involve tight submission deadlines and coordination across multiple time zones for global filings. |
| Type of Hiring Companies | CROs (Cognizant, IQVIA, Accenture), MNCs (Novartis, AstraZeneca), and IT-enabled PV service providers. | Pharma companies (Pfizer, Dr Reddy’s, Sun Pharma), CROs, and regulatory consultancies. |
| Career Outlook | Growing field due to the increasing global focus on patient safety and post-marketing surveillance. | Highly stable and in-demand profession driven by evolving global regulatory requirements. |
| Salary at the entry level | ₹5–7 LPA for Drug Safety Associates. | ₹6–8 LPA for Regulatory Affairs Associates. |
| Popular Job Roles | Drug Safety Associate, Pharmacovigilance Officer, Medical Reviewer, Signal Detection Specialist. | Regulatory Affairs Associate, Documentation Specialist, Labelling Coordinator, Regulatory Compliance Officer |
| Global opportunities | High demand in countries with established pharmacovigilance hubs (UK, EU, Canada, US, India). | Excellent global scope, as every pharmaceutical company requires regulatory professionals for market access. |
Conclusion
Both Pharmacovigilance and Regulatory Affairs are rewarding and impactful careers in the pharmaceutical industry. But pursuing a career in any of these fields is not a piece of cake. With proper training and career guidance from CareerInPharma, India’s best clinical research and pharma training institute, you can confidently step into either field and build a successful, long-term career in pharma.
