PHARMAFull-time
PV Officer (Medical Device & Product Experience)
By Admin · Pharmacovigilance & Drug Safety
PUNE (IN)HYBRIDPOSTED: 8/31/2026
PHARMAFull-time
HIRING ORGANIZATIONPRIMEVIGILANCETechnology
ROLE DEFINITION & RESPONSIBILITIES
Role Overview
This position sits within the ICSR (Individual Case Safety Report) Management unit at PrimeVigilance, a global pharmacovigilance specialist organization under Ergomed Group. The role focuses on end-to-end safety case processing, particularly involving medical device vigilance and pharmacovigilance operations. The position requires strict adherence to global regulatory standards, strong data quality oversight, and collaboration across clinical safety and quality teams.
Core Responsibilities
Perform end-to-end processing of ICSRs from multiple sources (clinical trials, post-marketing, spontaneous reports) within defined timelines and compliance frameworks.
Conduct intake, triage, medical assessment, and structured data entry of safety cases into validated safety databases.
Manage follow-up activities to ensure completeness and clinical accuracy of safety reports.
Handle SAE (Serious Adverse Event) and SUSAR (Suspected Unexpected Serious Adverse Reaction) workflows, including unblinding processes, protocol reviews, and Safety Management Plan alignment.
Execute reconciliation activities across clinical datasets, partner systems, and safety databases to ensure data consistency.
Process and evaluate medical device incident reports, ensuring proper classification of seriousness, causality, and regulatory reportability.
Technical & Domain Expertise
Apply working knowledge of EU MDR (2017/745) and global medical device vigilance requirements.
Perform MedDRA and WHO drug coding with precision and consistency.
Conduct quality control (QC) and quality review of safety cases, ensuring completeness, accuracy, and compliance with SOPs and regulatory standards.
Identify and resolve discrepancies in safety data across systems and reports.
Generate database outputs and safety reports for monthly client deliverables and regulatory submissions.
Ensure compliance with personal data protection and privacy regulations.
Cross-Functional Collaboration
Coordinate with Quality Assurance teams for Product Quality Complaint (PQC) handling.
Collaborate with clinical, regulatory, and partner teams for reconciliation and safety signal validation.
Support workflow planning and resource allocation within the ICSR unit.
Leadership & Mentorship
Mentor and train junior pharmacovigilance staff, ensuring adherence to quality and operational standards.
Contribute to process improvements and knowledge-sharing initiatives within the team.
Organizational Impact
Directly contributes to patient safety by ensuring accurate and timely reporting of adverse events and device incidents.
Supports regulatory compliance across global markets, minimizing risk for clients and improving safety signal detection.
Enhances operational efficiency through workflow management and quality oversight.
Company Environment & Values
Operates within a globally distributed team across Europe, North America, Asia, and beyond.
Emphasizes quality, integrity, agility, collaboration, and inclusivity.
Offers a purpose-driven environment focused on improving patient outcomes through safety intelligence.
REQUIRED VERIFIED SKILLS
Pharmacovigilance
ICSR Processing
Medical Device Vigilance
EU MDR 2017/745
SAE/SUSAR Management
MedDRA Coding
WHO Drug Coding
Safety Database Management
Case Processing
Quality Control
Regulatory Compliance
Data Reconciliation
Adverse Event Reporting
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
For professionals with 2–5 years of pharmacovigilance experience in India, compensation typically aligns with mid-level PV roles in CROs, with added value from global exposure and hybrid work flexibility. While exact salary is not disclosed, candidates can expect competitive industry-standard packages with potential performance-based incentives, learning opportunities, and long-term growth within a global CRO environment.
ORGANIZATION CONTEXT & CULTURE
PrimeVigilance is actively hiring for this position.
INDUSTRY: Technology
EXPECTED CAREER ROADMAP
This role provides a strong foundation in both pharmacovigilance and medical device vigilance, positioning candidates for progression into senior PV roles such as Senior Drug Safety Associate, PV Team Lead, or Safety Scientist. With exposure to global regulatory frameworks like EU MDR and end-to-end safety operations, professionals can transition into strategic roles in signal detection, risk management, or regulatory affairs. The mentorship responsibilities also build leadership capabilities, enabling future movement into people management or pharmacovigilance consulting roles within CROs or pharmaceutical companies.
APPLICATION ADVISORY
Focus your resume on hands-on ICSR processing experience, especially involving medical device vigilance and EU MDR exposure. Highlight familiarity with safety databases (e.g., Argus, ArisG), MedDRA coding, and regulatory compliance workflows. Be prepared to discuss real-case scenarios involving SAE/SUSAR handling, reconciliation challenges, and quality review processes. Demonstrating attention to detail and the ability to manage high-volume case processing under timelines will significantly improve your chances.
RECOMMENDED TRAINING
1/5
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