Pharmacovigilance Jobs In India: Parexel is Hiring a Drug Safety Specialist (Japanese) – Apply Now
Parexel is looking for a skilled Drug Safety Specialist (Japanese) to join its global pharmacovigilance team. This remote role offers an exciting opportunity to contribute to drug safety operations, regulatory compliance, and literature review processes across multiple therapeutic areas for those looking for Pharmacovigilance Jobs In India. If you are passionate about ensuring patient safety, possess strong analytical and communication skills, and are fluent in Japanese (JLPT N2 or above), Parexel invites you to bring your expertise to a dynamic, collaborative environment.
Job Details:
- Job Title: Drug Safety Specialist (Japanese)
- Location: Remote – India
- Category: Medical Sciences
About the Company:
Parexel is one of the world’s leading clinical research and biopharmaceutical service organizations, dedicated to advancing the development of innovative medicines and improving patient outcomes. With a global presence across more than 50 countries, Parexel partners with top pharmaceutical, biotechnology, and medical device companies to deliver clinical, regulatory, and drug safety solutions that accelerate product approvals and ensure patient safety. Known for its commitment to scientific excellence, Parexel provides comprehensive expertise in pharmacovigilance, regulatory affairs, clinical data management, and medical communications and offers Pharmacovigilance jobs. The company’s mission is to simplify the journey from molecule to market while upholding the highest standards of ethics, quality, and compliance. At Parexel, employees work in a collaborative, diverse, and inclusive environment that values innovation, learning, and professional growth. The organization’s strong focus on patient-centric research and global safety standards makes it a trusted partner for leading healthcare innovators worldwide.
Education:
- Degree in Life Sciences, Pharmacy, Biotechnology, or related field.
- Medical, Nursing, or Dentistry degrees are an added advantage.
Knowledge and Experience:
- Prior experience in pharmacovigilance or drug safety preferred.
- Knowledge of PMDA PV activities and working with Japanese-speaking teams.
- Understanding of medical terminology and safety data evaluation.
Key Accountabilities
General Responsibilities:
- Maintain up-to-date knowledge of adverse event safety profiles, drug labeling, and global safety regulations.
- Ensure compliance with global regulatory reporting obligations and internal SOPs.
- Assist in developing project-specific safety procedures, workflows, and templates.
- Participate in audits, inspections, and internal training sessions.
- Collaborate with clients to deliver high-quality safety deliverables.
- Mentor new team members and manage documentation efficiently.
Case Processing:
- Monitor incoming safety reports from multiple sources such as emails, EudraVigilance, and literature searches.
- Validate case completeness and medical cohesiveness before entry.
- Perform data entry, MedDRA coding, and narrative writing in safety databases.
- Conduct quality checks, case reconciliation, and compliance tracking.
- Generate line listings and tabulations for safety and periodic reports.
- Support compliance for ICSR submissions and corrective action documentation.
Drug Safety Reporting:
- Perform quality control of safety reports and tabulations.
- Develop expedited reporting procedures and maintain local reporting compliance.
- Manage safety report submissions to investigators and authorities.
- Track submission cases and reporting metrics.
Regulatory Affairs:
- Update regulatory databases with product lifecycle changes and submission details.
- Create reports for marketing authorization coordination.
- Conduct xEVMPD submissions and track acknowledgements via EMA Gateway.
Literature Search and Review:
- Develop and maintain search strategies to identify medical literature relevant to pharmacovigilance.
- Perform local and global literature searches, quality checks, and database updates.
- Collaborate with internal and external teams to address literature-related issues.
Skills Required:
- Strong understanding of drug safety, pharmacovigilance, and regulatory frameworks.
- Excellent communication skills in English and Japanese (JLPT N2 or above).
- Analytical thinking, problem-solving, and attention to detail.
- Proficiency in MS Office and web-based applications.
- Ability to manage multiple projects and meet deadlines effectively.
