Are you passionate about patient safety and regulatory compliance in the pharmaceutical industry? ProPharma, a global leader in life sciences consulting, is hiring a Pharmacovigilance Specialist, Case Processing in Bangalore to support groundbreaking drug and device programs. With over 20 years of expertise, ProPharma empowers biotech, med device, and pharmaceutical organizations to deliver innovative therapies. This full-time role offers a chance to contribute to high-impact pharmacovigilance processes in a dynamic, collaborative environment. Join a team dedicated to excellence and innovation in Bangalore, India’s biotech hub.
Key Responsibilities
As a Pharmacovigilance Specialist, you will play a critical role in ensuring the safety of clinical trial and post-marketed products. Your responsibilities include:
- Case Processing: Manage individual case safety reports (ICSRs), including coding with MedDRA, assessing seriousness, and determining expectedness at event and case levels.
- Narrative Creation: Write accurate and detailed medical narratives for adverse event cases.
- Follow-Up Activities: Identify and collect necessary follow-up information for case completion.
- Regulatory Compliance: Ensure timely submission of cases meeting expedited regulatory reporting criteria per SOPs and global safety regulations.
- Client Notifications: Provide timely case management updates to clients as required.
- Training Support: Contribute to developing and delivering training materials for pharmacovigilance processes.
- Quality Assurance: Perform peer reviews to ensure case accuracy, consistency, and quality.
- Issue Escalation: Highlight discrepancies or concerns to senior team members for resolution.
- Continuous Learning: Stay updated on global pharmacovigilance regulations and best practices.
Qualifications
To succeed in this role, candidates should meet the following requirements:
- Education: Bachelor’s degree in life sciences (required); advanced degree, RN, RPh, or PharmD (preferred).
- Experience: At least two years of experience in pharmacovigilance or related fields.
- Skills:
- Strong verbal, written, and interpersonal communication skills.
- High attention to detail and accuracy in case processing.
- Ability to identify and resolve problems efficiently.
- Excellent organizational and multitasking abilities.
- Basic knowledge of pharmacovigilance principles and MedDRA coding.
- Ability to work independently and collaboratively in a multidisciplinary team.
Why Join ProPharma?
ProPharma fosters a diverse, equitable, and inclusive workplace where employees can thrive as their authentic selves. Benefits include:
- Impactful Work: Contribute to patient safety and innovative therapies in a globally recognized organization.
- Collaborative Environment: Work with a multidisciplinary team in Bangalore’s vibrant life sciences ecosystem.
- Career Growth: Access opportunities for professional development and training in pharmacovigilance.
- Inclusive Culture: Be part of a company that celebrates diversity and encourages entrepreneurial thinking.
How to Apply
