Fresher Syneos Health Hiring Pharmacovigilance
Company: Syneos Health
Job Title: Japanese Language Expert – Safety & PV Specialist
Experience Required: 0+ years (Freshers are encouraged to apply)
Job Location: Remote (Hiring office in India)
Openings: 3 positions
Employment Type: Full-time, Permanent
Salary Package: 5 – 7 LPA
Educational Qualifications: B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Life Sciences, B.Tech, M.Tech, BDS, MDS, MBBS, Nursing
Application Deadline: April 2, 2025
Job Verification Status: Verified
Application Mode: Online Application
Job Overview
Syneos Health is currently hiring for the role of Japanese Language Expert – Safety & Pharmacovigilance (PV) Specialist. This is a remote position that provides an opportunity to work in a dynamic and growing field. The role primarily involves managing pharmacovigilance activities, ensuring compliance with global regulations, and supporting drug safety operations. This position is ideal for individuals with strong proficiency in Japanese language (reading, writing, and speaking) and a background in life sciences or healthcare. Fresher Syneos Health Hiring Pharmacovigilance
Key Responsibilities
As a Japanese Language Expert – Safety & PV Specialist, you will be responsible for various tasks related to drug safety, pharmacovigilance, and regulatory compliance. Your key duties will include: Fresher Syneos Health Hiring Pharmacovigilance
1. Workflow Coordination:
- Ensure smooth project execution by managing workload distribution across the team.
- Identify potential issues and escalate them promptly to the relevant stakeholders.
- Maintain seamless coordination with internal and external teams.
2. Safety & PV Risk Management:
- Assist in the identification, assessment, and mitigation of pharmacovigilance risks.
- Support drug safety teams in ensuring patient safety and regulatory compliance.
3. Regulatory Compliance & Case Processing:
- Process Individual Case Safety Reports (ICSRs) in accordance with global regulatory requirements.
- Ensure compliance with industry standards, including ICH-GCP, GVP, and local regulatory guidelines.
- Validate and enter safety data into pharmacovigilance databases.
4. Data Entry & Quality Control: Fresher Syneos Health Hiring Pharmacovigilance
- Enter case reports into safety databases (such as Argus, ARISg, VigiFlow, etc.).
- Conduct quality checks to ensure data accuracy and completeness.
- Identify and rectify discrepancies in safety data management.
5. Medical Coding & Safety Reporting:
- Perform MedDRA coding for adverse events, medical history, and concomitant medications.
- Generate and submit expedited and periodic safety reports in accordance with regulatory guidelines.
6. Audit & Inspection Support:
- Support regulatory audits and inspections.
- Ensure compliance with Trial Master File (TMF) requirements.
7. Training & Mentoring:
- Provide training sessions for investigators and junior team members on safety reporting guidelines.
- Ensure proper documentation and knowledge sharing within the pharmacovigilance team. Fresher Syneos Health Hiring Pharmacovigilance
Skills & Qualifications
Educational Background:
Candidates must possess a Bachelor’s or Master’s degree in any of the following fields: Fresher Syneos Health Hiring Pharmacovigilance
- Life Sciences
- Pharmacy (B.Pharm, M.Pharm, Pharm.D)
- Nursing
- Medical (MBBS, BDS, MDS)
- Engineering (B.Tech, M.Tech) with relevant experience
Language Proficiency:
- Fluency in Japanese (reading, writing, and speaking) is mandatory.
- Strong command of English for communication and documentation purposes.
Technical Skills:
- Familiarity with pharmacovigilance safety databases such as Argus, ARISg, VigiFlow, etc.
- Knowledge of medical terminology and safety reporting regulations.
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
Regulatory Knowledge:
- Understanding of ICH-GCP, GVP guidelines, and global pharmacovigilance regulations.
- Ability to work within the framework of international drug safety policies.
Soft Skills:
- Strong communication and interpersonal skills.
- Excellent time management and organizational skills.
- Ability to work independently and within a team.
- High attention to detail with a focus on accuracy and compliance.
About Syneos Health
Syneos Health (Nasdaq: SYNH) is a leading global contract research organization (CRO) that provides clinical, commercial, and consulting solutions to biopharmaceutical companies. With operations in over 110 countries, Syneos Health accelerates the development and commercialization of new medical treatments, offering integrated services across the entire drug development lifecycle. Fresher Syneos Health Hiring Pharmacovigilance
Why Join Syneos Health?
- Global Exposure: Work with top pharmaceutical companies worldwide.
- Career Growth: Gain valuable experience in pharmacovigilance, drug safety, and regulatory affairs.
- Remote Work Flexibility: Enjoy the benefits of working remotely from anywhere in India.
- Work-Life Balance: Flexible work schedules that promote a healthy balance between personal and professional life.
- Diverse and Inclusive Work Culture: Be part of a multicultural and inclusive environment that values professional development.
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How to Apply?
Interested candidates can apply online before April 2, 2025. Ensure that you meet all the eligibility criteria before submitting your application.
Don’t miss this opportunity! Apply now to build a rewarding career in Pharmacovigilance with Syneos Health! Fresher Syneos Health Hiring Pharmacovigilance