Drug Safety Specialist – Japanese | Parexel

Drug Safety Specialist – Japanese | Parexel | India

Parexel hiring Drug Safety Specialist – Japanese. Apply now! Life Sciences/Biomedical graduates, remote, multiple vacancies in India

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In the fast-paced field of pharmacovigilance, Parexel is seeking an experienced Drug Safety Specialist – Japanese to join its global team. This remote-based opportunity in India allows qualified professionals to contribute to drug safety monitoring, regulatory compliance, and medical case processing while working with an industry-leading organization committed to advancing healthcare outcomes.

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Company Overview

Parexel International is a global leader in clinical research services, regulatory consulting, and pharmacovigilance solutions. With a mission to accelerate drug development and improve patient outcomes, Parexel provides intelligent connections between innovative treatments and the global healthcare ecosystem. Their focus on quality, compliance, and patient safety makes them a preferred partner for pharmaceutical companies worldwide.

• Headquarters: Waltham, Massachusetts, USA

• Global operations in over 50 countries

• Expertise in Clinical Trials, Regulatory Affairs, and Drug Safety

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Job Role & Responsibilities

As a Drug Safety Specialist – Japanese, your primary responsibilities include:

General Duties:

• Maintain knowledge of drug safety profiles, labeling documents, SOPs, and global safety regulations.

• Ensure timely compliance with internal and regulatory reporting obligations.

• Assist in creating project-specific safety procedures, workflows, and templates.

• Conduct and attend internal and client-specific training sessions.

• Participate in audits and inspections, maintaining high-quality deliverables.

• Delegate tasks to Drug Safety Assistants and mentor new team members.

• Collaborate with client teams to ensure accurate and high-quality deliverables.

Case Processing:

• Monitor incoming safety reports from multiple sources such as Eudravigilance, literature, and client communications.

• Triage and review reports for completeness, medical cohesiveness, and compliance.

• Perform accurate data entry into safety databases and MedDRA coding.

• Prepare medically cohesive case narratives and perform quality checks.

• Conduct literature searches, case reconciliation, and generate line listings and tabulations.

• Support compliance activities including late case investigation and corrective action documentation.

Drug Safety Reporting & Regulatory Affairs:

• Ensure quality control of case reports and develop expedited reporting procedures.

• Maintain local and global drug safety reporting requirements.

• Submit safety reports to investigators and track all regulatory submissions.

• Manage regulatory database updates, variations, and product lifecycle tracking.

• Generate marketing authorization status reports and xEVMPD submissions via EMA Gateway.

Skills Required:

• Sound knowledge of pharmacovigilance and drug development process.

• Proficiency in global safety regulations and case processing standards.

• Strong analytical, problem-solving, and presentation skills.

• Expertise in database/literature searches, Microsoft Office, and web-based applications.

• Excellent verbal and written communication in English and Japanese (JLPT N2 or above).

• Strong organizational and prioritization abilities to manage multiple tasks.

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Eligibility / Qualifications

Education:

• Degree in Life Sciences, Health, or Biomedical Sciences such as Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Medicine, Dentistry, Nursing, or relevant Pharmacovigilance experience.

Experience:

• Prior experience in drug safety/pharmacovigilance highly desirable.

• Familiarity with PMDA PV activities and Japanese-speaking PV case processing teams.

• Good understanding of medical terminology and regulatory submission processes.

Language Requirement:

• Japanese (JLPT N2 or above) proficiency mandatory.

• Fluent English communication skills.

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Location & Salary

• Primary Location: India (Remote)

• Job Type: Full-time, Remote

• Compensation: Competitive, commensurate with experience (exact figures based on company standards).

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Application Process

Interested candidates can Apply Here to join Parexel’s dynamic pharmacovigilance team. Don’t miss this opportunity to enhance your career in drug safety with a global leader!

Apply before to secure your spot and work on international pharmacovigilance projects with Japanese clients.

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FAQs

Q1: What are the eligibility criteria?
A1: Applicants must hold a degree in Life Sciences, Health, or Biomedical Sciences with experience in pharmacovigilance. JLPT N2 or above is required.

Q2: Is this position remote?
A2: Yes, this role is fully remote within India.

Q3: What experience is needed?
A3: Prior drug safety/pharmacovigilance experience is desirable. Familiarity with PMDA PV processes is a plus.

Q4: How can I apply?
A4: Submit your application via the Parexel career portal here.

Q5: Are there any language requirements?
A5: Candidates must be proficient in Japanese (JLPT N2 or above) and fluent in English.

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Relevant Courses (for SEO & applicant clarity)

Pharmacy, Biochemistry, Microbiology, Biotechnology, Biophysics, Biomedical Sciences, Nursing, Medicine, Dentistry, Experimental Medicine, Clinical Research, Life Sciences, Health Sciences

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