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Regulatory Affairs & Pharmacovigilance Jobs at ProPharma India
Looking to advance your career in regulatory affairs jobs or pharmacovigilance jobs in India? Join ProPharma, a trusted global leader in life sciences consulting. As a Pharmacovigilance Specialist, you’ll play a key role in ensuring drug safety, regulatory compliance, and patient well-being. This opportunity offers hands-on experience across clinical and post-marketed safety reporting, setting the stage for a rewarding career with one of the most respected names in global healthcare – ProPharma careers are built for impact, innovation, and growth.
Job Details:
- Job Position: Pharmacovigilance Specialist
- Job Requisition ID: JR 8350
About the Company:
For more than two decades, ProPharma has been a pioneer in advancing global health by supporting biotech, medical device, and pharmaceutical organizations through its advise-build-operate model. Known for excellence in regulatory affairs jobs, pharmacovigilance jobs, and R&D consulting, ProPharma careers offer opportunities to collaborate with world-class experts and help deliver safe, effective therapies to patients worldwide.
Educational Requirements:
Bachelor’s degree in life sciences.
Experience Requirements:
Minimum two years of related work experience in pharmacovigilance jobs
or regulatory affairs jobs.Job Description:
As a Pharmacovigilance Specialist, you will be responsible for managing individual case safety reports, performing initial case-level assessments of seriousness and expectedness, and creating accurate medical narratives. This position plays a critical role in supporting regulatory affairs jobs and ensuring all safety data meets global standards. You’ll work closely with internal teams to maintain compliance and uphold ProPharma’s reputation for high-quality safety operations.
Regulatory Affairs Job Key Responsibilities:
- Manage daily case processing of adverse event reports from clinical trials and post-marketed products.
- Code cases using MedDRA and assess seriousness and expectedness at the event and case level.
- Conduct case follow-up activities to collect and verify missing or unclear data.
- Create and review thorough case narratives.
- Notify clients as required during case management.
- Support the development and delivery of pharmacovigilance training materials.
- Identify and escalate issues or discrepancies to the Principal PV Specialist or Manager.
- Maintain current knowledge of global drug safety and regulatory reporting standards.
- Peer-review cases to ensure accuracy and consistency.
- Participate in projects related to regulatory affairs jobs and process improvement within the PV team.
Regulatory Affairs and Pharmacovigilance Job Necessary Skills and Abilities:
- Excellent communication, writing, and teamwork skills.
- Strong attention to detail and analytical mindset.
- Ability to prioritize tasks and manage multiple projects.
- Proficiency in pharmacovigilance concepts and regulatory reporting.
- Capability to work independently while supporting cross-functional teams in ProPharma careers.
