ProPharma Senior Pharmacovigilance Specialist Jobs
Exciting ProPharma Senior Pharmacovigilance Specialist Jobs | Remote PV Careers
ProPharma is hiring a Senior Pharmacovigilance Specialist for its India operations. This remote opportunity is ideal for experienced pharmacovigilance professionals looking to advance their careers in drug safety, adverse event case processing, regulatory compliance, and global pharmacovigilance operations.
Candidates with experience in Individual Case Safety Reports (ICSRs), adverse event reporting, MedDRA coding, safety database management, and global drug safety regulations are encouraged to apply. This role offers the opportunity to work with a leading life sciences consulting organization supporting pharmaceutical, biotechnology, and medical device companies worldwide.
Company Overview
ProPharma has been supporting pharmaceutical, biotechnology, and medical device organizations for more than 25 years through regulatory sciences, clinical research, pharmacovigilance, quality compliance, medical information, and R&D consulting services.
The company partners with global healthcare organizations throughout the product lifecycle, helping accelerate scientific innovation while maintaining the highest standards of patient safety and regulatory compliance.
Job Role & Responsibilities
As a Senior Pharmacovigilance Specialist, you will be responsible for managing and reviewing adverse event cases while ensuring compliance with global pharmacovigilance regulations and client requirements.
Key Responsibilities
Case Processing & Safety Reporting
- Process and review adverse event cases from clinical trials and post-marketing sources.
- Perform MedDRA coding for adverse events.
- Assess seriousness and expectedness at event and case levels.
- Conduct follow-up activities for missing safety information.
- Create and review case narratives.
- Provide client notifications related to case management activities.
Pharmacovigilance Operations
- Support pharmacovigilance case processing activities.
- Ensure compliance with global drug safety regulations.
- Perform peer review of safety cases for quality and accuracy.
- Conduct Healthcare Professional (HCP) reviews when required.
- Identify discrepancies and escalate concerns appropriately.
Training & Leadership
- Support development of pharmacovigilance training materials.
- Deliver training to team members.
- Mentor and guide junior pharmacovigilance professionals.
- Serve as a pharmacovigilance subject matter expert for assigned projects.
Regulatory Compliance
- Maintain current knowledge of global pharmacovigilance regulations.
- Ensure adherence to regulatory reporting timelines.
- Support quality improvement initiatives within pharmacovigilance operations.
Eligibility / Qualifications
Educational Qualification
Required:
- Bachelor’s Degree in Life Sciences
Preferred Qualifications
- M.Pharm
- Pharm.D
- B.Pharm
- M.Sc Life Sciences
- Registered Nurse (RN)
- Registered Pharmacist (RPh)
- Advanced Degree in Life Sciences or Healthcare
Eligible Courses
B.Pharm, M.Pharm, Pharm.D, B.Sc Life Sciences, M.Sc Life Sciences, Biotechnology, Microbiology, Biochemistry, Nursing, Clinical Research, Pharmaceutical Sciences, Medical Sciences, Healthcare Sciences.
Experience Required
- Minimum 3 years of relevant Pharmacovigilance experience.
Candidates with experience in:
- Adverse Event Processing
- ICSR Management
- Drug Safety Operations
- Clinical Trial Safety
- Post-Marketing Surveillance
- Global Pharmacovigilance
will be preferred.
Required Skills
Pharmacovigilance Skills
- Pharmacovigilance
- Drug Safety
- Adverse Event Reporting
- ICSR Processing
- MedDRA Coding
- Safety Narrative Writing
- Case Follow-Up
- Regulatory Compliance
- Signal Detection Awareness
- Safety Data Review
Safety Systems Knowledge
Experience with one or more of the following:
- Oracle Argus Safety
- ARISg
- Safety Databases
- Pharmacovigilance Systems
Professional Skills
- Project Management
- Communication Skills
- Team Collaboration
- Quality Review
- Problem Solving
- Attention to Detail
- Training & Mentoring
Location & Salary
Location: India (Remote)
Approximate Salary: ₹10 LPA – ₹18 LPA
Salary may vary based on experience, skill set, project requirements, and organizational policies.
Why Join ProPharma?
- Remote work flexibility.
- Exposure to global pharmacovigilance projects.
- Opportunity to work with leading pharmaceutical and biotechnology clients.
- Career growth in drug safety and regulatory compliance.
- International exposure to global safety regulations and reporting standards.
- Collaborative and inclusive work environment.
Application Process
Interested candidates can apply directly through the official ProPharma careers portal:
Application Link: https://propharmagroup.wd1.myworkdayjobs.com/ppgcareers/job/India/Senior-Pharmacovigilance-Specialist_JR9689
Applicants are encouraged to update their resume with relevant pharmacovigilance experience, safety database expertise, and regulatory knowledge before applying.
Frequently Asked Questions (FAQs)
1. What qualification is required for this role?
A Bachelor’s degree in Life Sciences is required. Advanced degrees such as M.Pharm, Pharm.D, or related qualifications are preferred.
2. How much experience is required?
Candidates should have a minimum of 3 years of pharmacovigilance or drug safety experience.
3. Is this a remote opportunity?
Yes. The role is open for candidates across India and supports remote working.
4. Which pharmacovigilance systems are preferred?
Experience with Oracle Argus Safety, ARISg, or similar safety databases is preferred.
5. What are the major responsibilities?
The role involves adverse event processing, MedDRA coding, case narrative writing, peer review, safety reporting, and mentoring junior staff.
6. Is prior ICSR experience required?
Yes. Experience handling Individual Case Safety Reports (ICSRs) is highly valuable for this position.
Job Summary
| Category | Details |
|---|---|
| Company | ProPharma |
| Department Vacancies | Senior Pharmacovigilance Specialist |
| Qualification | Bachelor’s Degree in Life Sciences, B.Pharm, M.Pharm, Pharm.D, Nursing |
| Experience | Minimum 3 Years |
| Location | India (Remote) |
To apply for this job please visit propharmagroup.wd1.myworkdayjobs.com.
