Job Title:
Principal Pharmacovigilance Specialist
Company:
ProPharma Group
Job ID / Requisition:
JR 7775
Location:
India
Employment Type:
Full-time
Posted:
4 Days Ago
Company Overview:
ProPharma has over 20 years of experience supporting biotech, medical device, and pharmaceutical organizations. Operating across the full product lifecycle, ProPharma offers consulting solutions in regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology, enabling clients to de-risk and accelerate high-profile drug and device programs.
Role Overview:
The Principal Pharmacovigilance (PV) Specialist serves as a subject matter expert in PV, providing oversight, guidance, and mentorship. The role supports both internal teams and clients, ensuring high-quality case processing, adherence to global safety regulations, and effective training and documentation practices.
Key Responsibilities:
Pharmacovigilance Oversight:
Provide PV subject matter expertise and guidance internally and to clients.
Oversee development of project-specific working practices, work instructions, and other documentation (e.g., Safety Data Exchange Agreements, PV Agreements).
Serve as a resource for the Case Processing team on complex cases and escalated inquiries.
Perform case follow-up activities, including identification of additional information needed.
Create and review case narratives.
Provide client notifications for case management as required.
Training & Mentorship:
Support development and delivery of training materials.
Mentor and train less experienced PV staff.
Quality & Compliance:
Peer review cases for quality, consistency, and accuracy.
Conduct Health Care Professional (HCP) review as required.
Highlight discrepancies or areas of concern to the Principal PV Specialist, Case Processing, or Manager, Case Processing.
Maintain up-to-date knowledge of global PV regulations and standards.
Other Duties:
Perform additional tasks as assigned to support PV operations and client services.
Required Skills & Competencies:
Strong verbal, written, and interpersonal communication skills.
Excellent project management skills.
High accuracy and attention to detail.
Advanced problem-solving and decision-making abilities.
Ability to work independently and collaboratively in a multidisciplinary team.
Excellent organizational and prioritization skills.
Advanced knowledge of pharmacovigilance and PV systems (e.g., Oracle Argus Safety, ARISg).
Self-motivated, efficient, and capable of managing multiple projects and clients.
Education Requirements:
Required: Bachelor’s degree in Life Sciences.
Preferred: Advanced degree, RN, RPh, PharmD, or equivalent.
Experience Requirements:
Minimum 10 years of relevant work experience in pharmacovigilance or related fields.
Diversity & Inclusion Statement:
ProPharma values diversity, equity, and inclusion, fostering an environment where employees can be their authentic selves. The company encourages innovation, collaboration, and entrepreneurial thinking while providing a safe and empowering workspace.
Note:
ProPharma does not accept unsolicited resumes from recruiters or third parties. Please do not contact employees regarding this posting.
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