PV Officer (Medical Device & Product experience)
PrimeVigilance · Pune · onsite · Posted 44d ago
About a minute. You'll make an account on the way through.
About this role
- Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):
- Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
- Performing ICSR follow up
- SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
- Reconciliation (clinical, partners)
- Intake, triage, assessment, data entry, follow-up and processing of medical device safety / incident reports.
- Performing quality review/QC of medical device cases, ensuring completeness, accuracy, consistency, coding and adherence to SOPs.
- Personal data protection
- Product Quality Complaint handling and interaction with Quality Assurance
- MedDRA and WHO coding
- Database Outputs and Reports (including data for monthly reporting to clients)
- Workflow & resource management
- Mentoring and training of new and more junior employees within the department Qualifications
- Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
- Demonstrated experience in pharmacovigilance and medical device vigilance
- Good working knowledge of EU MDR (2017/745) and medical device vigilance concepts, including seriousness, reportability, device-relatedness and regulatory reporting requirements.
- Experience with global/European medical device cases and safety databases; ability to identify data discrepancies and ensure cases meet required quality and compliance standards.
- Excellent communication (written and verbal) skills
- Organization skills, including attention to details and multitasking
- Delegation skills
- Planning and time management
- Technical skills
- Team working
- English - fluent (spoken, written)
- Advanced literacy (MS Office)
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
About PrimeVigilance
PrimeVigilance
501-1000
employees
2008
18 years old
Guildford
United Kingdom
₹9.7L PA avg
Avg at PrimeVigilance
About
PrimeVigilance, an Ergomed company, was set up by former Pharmacovigilance Regulators in 2008. We have grown to become the leading Pharmacovigilance specialist company, delivering global solutions for both clinical safety and post-marketing pharmacovigilance, as well as medical information from our offices. Having successfully delivered Pharmacovigilance (PV) and Medical Information (MI) services for over 14 years, our experience enables us to offer a comprehensive, top quality, cost-effective, and innovative safety solution. Our flexible approach, tailor-made to work with clients, allows us to deliver the services that meet your clinical and post-marketing needs.
From its operational hubs based in Europe, the USA, and Japan. PrimeVigilance manages a global Pharmacovigilance system with a choice of leading drug safety databases, stretching to more than 100 countries.
• 900+ highly qualified professionals
• Global leader in QPPV services
• 24/7 multilingual call center
• Choice of leading drug safety databases
• Robotic Process Automation (RPA) expertise
• Access to regulatory experts and key opinion leaders
GLOBAL LIFE CYCLE MANAGEMENT SERVICES
• PHARMACOVIGILANCE
• PHARMACOEPIDEMIOLOGY & BENEFIT-RISK MANAGEMENT
• AUDIT & INSPECTION
• QUALITY MANAGEMENT
• REGULATORY SCIENCE
Industries
Employee ratings
9 reviews
Culture
3.4
Career growth
2.9
Work-life
3.7
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