PV Officer – Medical Device & Product
Job Details
Company: PrimeVigilance / Ergomed Group
Department: ICSR Management
Location: Pune, Maharashtra, India
Work Model: Hybrid
Employment Type: Full-time
Functional Area: Pharmacovigilance / ICSR Management
Specialization: Medical Device & Product Safety
Company Overview
PrimeVigilance is a global pharmacovigilance specialist focused on patient safety across the pharmaceutical and healthcare product lifecycle.
The organization supports clients with pharmacovigilance activities ranging from early development through post-marketing surveillance. Its work includes safety data processing, signal identification, regulatory compliance, and safety insights.
The company operates across multiple regions, including Europe, North America, South America, Asia, and Australia, with an emphasis on collaboration, flexibility, professional growth, quality, and patient safety.
Role Overview
The PV Officer will support activities within the Individual Case Safety Report (ICSR) Management function, with a particular focus on medical device vigilance and product safety.
The role involves end-to-end processing of safety cases, medical device incident reports, follow-up activities, reconciliation, coding, quality review, reporting, and compliance with applicable regulations and client-specific requirements.
The position also involves supporting SAE/SUSAR activities, product quality complaints, database reporting, workflow management, and mentoring junior team members.
Key Responsibilities
ICSR Management
Process Individual Case Safety Reports (ICSRs) received from various sources.
Ensure case processing is performed according to:
Applicable regulatory requirements
PrimeVigilance procedures
Client-specific requirements
Agreed timelines
Perform case intake, triage, assessment, data entry, follow-up, and processing.
Ensure cases are complete, accurate, consistent, and compliant with applicable procedures.
Identify and resolve discrepancies in safety information.
ICSR Follow-Up
Perform follow-up activities for safety cases.
Identify missing or clinically relevant information.
Coordinate follow-up requests as required.
Ensure follow-up activities are appropriately documented.
Track outstanding information within required timelines.
SAE/SUSAR Management
Support SAE/SUSAR management activities, including:
Unblinding activities
Clinical trial reconciliation
Protocol review
Safety Management Plan review
Case assessment and reconciliation
Coordination with relevant stakeholders
Medical Device Vigilance
Intake and triage medical device safety and incident reports.
Assess medical device safety cases for completeness and reportability.
Perform medical device case data entry and processing.
Conduct follow-up activities for medical device incidents.
Assess:
Seriousness
Reportability
Device-relatedness
Relevant regulatory reporting requirements
Ensure medical device cases comply with applicable regulatory requirements and client procedures.
Medical Device Case Quality Review / QC
Perform quality review and QC of medical device cases.
Ensure completeness and accuracy of case information.
Verify consistency of case data.
Review appropriate medical and product coding.
Ensure compliance with SOPs and client-specific requirements.
Identify discrepancies and coordinate appropriate corrections.
Medical Device Regulatory Knowledge
The role requires good working knowledge of EU MDR 2017/745 and medical device vigilance principles, including:
Medical device incident reporting
Seriousness assessment
Reportability assessment
Device-relatedness
Regulatory reporting requirements
European medical device vigilance requirements
Global medical device safety case processing
Reconciliation
Perform clinical reconciliation activities.
Support partner reconciliation.
Identify discrepancies between safety databases and source systems.
Investigate and resolve reconciliation findings.
Maintain appropriate documentation of reconciliation activities.
Product Quality Complaints
Support Product Quality Complaint handling.
Collaborate with Quality Assurance teams.
Identify safety information associated with product quality complaints.
Ensure appropriate communication between Pharmacovigilance and Quality functions.
Support accurate documentation and processing of relevant safety information.
Medical Coding
Perform appropriate coding using established medical terminology systems, including:
MedDRA
WHO Drug / WHO coding
Ensure coding is accurate, consistent, and aligned with applicable procedures.
Database Outputs and Reporting
Generate and review database outputs.
Support preparation of safety data for client reporting.
Provide data required for monthly client reporting.
Ensure reports and database outputs are accurate and delivered within agreed timelines.
Data Privacy and Personal Data Protection
Handle personal and patient information in accordance with applicable data protection requirements.
Maintain confidentiality of sensitive safety information.
Ensure personal data is appropriately managed throughout case processing activities.
Workflow and Resource Management
Support effective workflow management within the ICSR team.
Prioritize assigned cases and activities according to urgency and regulatory timelines.
Support workload planning and resource allocation.
Ensure deliverables are completed within agreed timelines.
Escalate workload or operational risks when necessary.
Mentoring and Training
Mentor new and junior employees within the department.
Provide process guidance and practical support.
Assist with training and onboarding activities.
Promote consistent application of SOPs and quality standards.
Support knowledge sharing within the team.
Qualifications
Degree in a life sciences discipline, pharmacy, nursing, or another healthcare-related field.
Relevant pharmacovigilance experience may also be considered.
Demonstrated experience in:
Pharmacovigilance
ICSR processing
Medical device vigilance
Product safety
Required Technical Knowledge
Good understanding of pharmacovigilance principles.
Working knowledge of medical device vigilance.
Good understanding of EU MDR 2017/745.
Knowledge of medical device case processing.
Understanding of seriousness and reportability assessment.
Understanding of device-relatedness assessment.
Experience with global and/or European medical device cases.
Experience working with safety databases.
Ability to identify case discrepancies.
Knowledge of MedDRA and WHO coding.
Understanding of regulatory and SOP requirements.
Advanced proficiency in Microsoft Office tools.
Core Competencies
Communication
Excellent written and verbal English communication skills.
Ability to communicate effectively with internal teams, clients, and stakeholders.
Ability to clearly document case assessments and follow-up activities.
Organization and Attention to Detail
Strong organizational skills.
High attention to detail.
Ability to manage multiple activities simultaneously.
Ability to prioritize work based on regulatory and business requirements.
Planning and Time Management
Strong planning and time-management skills.
Ability to meet case-processing and reporting deadlines.
Ability to manage competing priorities effectively.
Leadership and Delegation
Ability to delegate tasks appropriately.
Ability to mentor and guide junior team members.
Ability to support team workflow and resource management.
Teamwork
Strong collaborative approach.
Ability to work effectively within cross-functional and international teams.
Willingness to support colleagues and share knowledge.
Language Requirement
English: Fluent in both spoken and written communication.
Key Functional Areas
Pharmacovigilance
ICSR Management
Medical Device Vigilance
Product Safety
Medical Device Incident Reporting
SAE/SUSAR Management
Case Intake and Triage
Case Processing
Follow-Up Management
MedDRA Coding
WHO Coding
Reconciliation
Quality Review / QC
Product Quality Complaints
Safety Database Management
EU MDR Compliance
Regulatory Reporting
Data Privacy
Client Reporting
Workflow Management
Team Mentoring
Ideal Candidate Profile
The ideal candidate is a pharmacovigilance professional with experience in ICSR processing and medical device vigilance, preferably with exposure to European/global medical device cases.
The candidate should have a strong understanding of EU MDR 2017/745, medical device incident reporting, seriousness, reportability, device-relatedness, safety databases, MedDRA coding, reconciliation, and case quality review.
Strong attention to detail, communication, organization, time management, and teamwork skills are essential.
Experience mentoring junior team members and supporting workflow or resource management would be an additional advantage.
Key Success Factors
Success in this role will depend on the ability to:
Process safety cases accurately and within timelines.
Apply medical device vigilance requirements correctly.
Identify and resolve case discrepancies.
Maintain high-quality case documentation.
Perform effective QC and reconciliation.
Understand and apply EU MDR requirements.
Manage multiple priorities while maintaining quality.
Communicate effectively with stakeholders.
Support and mentor junior team members.
Maintain a strong focus on patient safety and regulatory compliance.
Company Values
PrimeVigilance/Ergomed Group emphasizes:
Quality: Maintaining the standards expected for patient safety.
Integrity and Trust: Acting responsibly and ethically.
Drive and Passion: Maintaining focus on meaningful outcomes.
Agility and Responsiveness: Responding quickly to patient safety requirements.
Belonging: Creating an inclusive environment where everyone can contribute.
Collaborative Partnerships: Working together to achieve better outcomes.
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