PV Officer (Medical Device & Product experience)

Ergomed; Maharashtra; On-site; INR 600,000 - 900,000; Full time

Job summary

Ergomed is seeking a Pharmacovigilance professional to join our global team, focusing on processing individual case safety reports and ensuring regulatory compliance across medical device vigilance. You will support SAE/SUSAR management, data entry, QC, and client reporting.

Ideal candidates will have a life science background with PV exposure, strong English communication, and proficiency in MS Office. The role emphasizes accuracy, time management, and collaborative teamwork within a global PV

Qualifications

• Life science graduates or healthcare qualification with pharmacovigilance exposure.
• Demonstrated experience in pharmacovigilance and medical device vigilance.
• Good knowledge of EU MDR (2017/745) and device vigilance concepts.

Responsibilities

• Perform ICSR processing from all sources in accordance with regulations and client requirements.
• Perform SAE/SUSAR management (unblinding, reconciliation, protocol review).
• Conduct intake, triage, assessment, data entry, follow-up and processing of medical device safety reports.
• Perform quality review/QC of medical device cases, ensuring accuracy and SOP compliance.
• Protect personal data and interact with Quality Assurance for product quality complaints.
• Handle MedDRA and WHO coding and generate data for monthly client reporting.

Skills

Excellent communication

Organization skills

Time management

Teamwork

English fluent

MS Office proficiency

Education

Life science graduate or healthcare qualification

Experience in pharmacovigilance

Tools

MS Office

Job description

Medicine moves forward here. So will you.

At PrimeVigilance, patient safety is not one part of the job. It is why we exist.

We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.

That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from.

If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.

• 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,PrimeVigilanceprocedures and in accordance with client specific requirements and timelines
• Performing ICSR followup
• 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 WHOcoding
• 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

• 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 andmultitasking
• Delegation skills
• Planning and time management
• Technical skills
• Team working
• English – fluent (spoken, written)
• Advanced literacy (MS Office)

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You'll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

• Quality: we hold ourselves to the standard patients deserve.

• Integrity and trust: we do the right thing, especially when it is hard.

• Drive and passion: we care about the outcome, because someone is waiting on it.

• Agility and responsiveness: we move quickly, because patients cannot wait.

• Belonging: everyone is welcome, and every voice counts.

• Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.