Senior PV Officer

PrimeVigilance Ltd.; Pune District; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

PrimeVigilance Ltd. is seeking an experienced pharmacovigilance professional to join our global ICSR team in Pune. The role focuses on processing safety reports, ensuring regulatory compliance, and supporting client projects.

You will guide ICSR activities, contribute to data interpretation, and mentor junior colleagues while collaborating with cross-functional teams to safeguard patient safety.

Qualifications

• Life science or healthcare qualification, or pharmacovigilance experience.

Responsibilities

• Provide support to project team activities for clients.
• Process ICSRs from all sources per regulations and timelines.
• Perform ICSR follow-up and SAE/SUSAR management.
• Perform reconciliation with clinical partners.
• Handle personal data protection and QA interactions.
• Work with MedDRA and WHO coding.
• Generate database outputs and monthly client reports.
• Mentor and train junior staff in the department.

Education

Life science degree

Healthcare qualification or pharmacovigilance experience

Pharmacovigilance experience (10-12 years)

English fluency (written & spoken)

Communication skills

Organization & multitasking

Delegation

Planning & time management

Technical skills

Teamwork

Tools

MS Office

Job description

Company Description

Medicine moves forward here. So will you.

Company 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.

Job Description

• Providing support to other activities undertaken by the project team on behalf of the client and the company
• Performing activities in the scope of ICSR management unit within agreed extent and imeframe (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)
• Personal data protection
• Product Quality Complaint handling and interaction with Quality Assurance
• Medical Information interaction
• 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
• Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
• Supporting ICSR SMEs or contributing as one of ICSR SMEs
• More senior colleague may perform tasks assigned as per SOP to more junior position
• Performing activities in the scope of ICSR management unit within agreed extent and Timeframe
• Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

Qualifications

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
• 10-12 years of work experience in pharmacovigilance
• 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)

Additional Information

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.