PV Physician I / II (Fluent in Japanese) Pharmacovigilance

PV Physician I / II (Fluent in Japanese) Pharmacovigilance Location: Pune, India (Remote Flexibility Available)

Job Type: 1-Year Fixed-Term Contract

Department: PV Medical Group

Company: PrimeVigilance

Experience Required: Minimum 26 years in Pharmacovigilance (Freshers Not Eligible)

About the Company

PrimeVigilance, part of the Ergomed Group, is a globally established pharmacovigilance and medical services organization. Since its inception in 2008, the company has demonstrated consistent international growth, supporting pharmaceutical, biotechnology, and medical device clients across Europe, North America, and Asia.

With expertise spanning Pharmacovigilance, Medical Information, Regulatory Affairs, and Quality Assurance, PrimeVigilance delivers high-quality, compliant safety solutions across all therapeutic areas.

Job Overview

The PV Physician I / II will be responsible for medical review, evaluation, and risk assessment of safety data, including Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs). This role requires strong expertise in pharmacovigilance processes, signal detection, and aggregate reporting, along with advanced proficiency in both English and Japanese.

Key Responsibilities

Medical Review and Case Processing

Perform medical and causality assessment of post-marketing ICSRs and clinical trial SAE reports

Evaluate seriousness, expectedness, listedness, and company causality

Review coding accuracy and ensure data quality in safety databases

Provide medical comments and follow-up queries where required

Regulatory and Safety Oversight

Act as Qualified Person for Pharmacovigilance (QPPV) or support QPPV activities

Contribute to Periodic Safety Update Reports (PSUR/PBRER) and Development Safety Update Reports (DSUR)

Review scientific literature for safety signals and case identification

Support responses to global regulatory authority queries

Signal Detection and Risk Management

Participate in signal detection activities, including data review and signal validation

Evaluate and categorize potential safety signals and recommend risk mitigation strategies

Contribute to benefit-risk assessment reports and Risk Management Plans (RMPs)

Review line listings and support safety review meetings

Required Qualifications

Medical degree (MBBS or equivalent) is mandatory

26 years of hands-on experience in Pharmacovigilance or Drug Safety

Strong expertise in ICSR review, aggregate reporting (PBRER, DSUR), and signal detection

Proficiency in English and Japanese (spoken and written mandatory)

Advanced knowledge of global pharmacovigilance regulations and ICH guidelines

Strong analytical, communication, and presentation skills

Ability to manage multiple projects in a cross-functional, global environment

Proficiency in MS Office tools

Why Join PrimeVigilance

Global exposure across diverse pharmacovigilance projects and therapeutic areas

Structured training programs and continuous professional development

Inclusive, employee-centric workplace culture

Strong emphasis on work-life balance and employee well-being

Opportunity to collaborate with international teams in a dynamic environment

Important Note for Applicants

This is a specialized pharmacovigilance physician role requiring prior industry experience and medical qualification. Freshers are advised to begin with entry-level roles such as Drug Safety Associate or Pharmacovigilance Associate before progressing to physician-level positions.

How to Apply

Apply through the official company careers page or trusted global job platforms. For more verified pharmacovigilance and clinical research jobs, visit ThePharmaDaily.com .