Remote Job PV Operations QMS Support Principal Scientist at Alphanumeric with QMS, CAPA, audit, and regulatory expertise for global projects.
Company Overview
Alphanumeric Systems Inc. is a globally recognized organization providing advanced business and technology solutions to leading pharmaceutical and life sciences companies. The company collaborates with some of the world’s top pharma brands, delivering high-quality support across pharmacovigilance, regulatory, and clinical operations.
This opportunity is part of a large-scale global pharmacovigilance project, offering professionals in India a chance to work remotely while contributing to international drug safety systems and compliance frameworks.
Job Location & Employment Type
- Location: India (100% Remote Work)
- Employment Type: Full-Time (Fixed-Term Project)
Open Positions / Department Details
- Role: Pharmacovigilance QMS Support Principal Scientist
- Department: Pharmacovigilance Operations / Quality Assurance
This role focuses on maintaining and improving Quality Management Systems (QMS) within pharmacovigilance operations while ensuring compliance with global regulatory standards.
📊 Job Overview (Quick Details)
| Job Title | PV Operations QMS Support Principal Scientist |
|---|---|
| Company | Alphanumeric Systems Inc. |
| Location | Remote (India) |
| Employment Type | Full-Time (Fixed-Term) |
| Department | Pharmacovigilance / Quality Assurance |
| Experience Required | 3–5 Years PV + 1–2 Years Quality |
| Qualification | Life Sciences / Pharmacy / Nursing |
| Salary | As per company norms |
| Mode of Application | Online |
Key Roles & Responsibilities
The selected candidate will be responsible for ensuring smooth functioning of pharmacovigilance quality systems and compliance processes. Key responsibilities include:
- Oversee and manage deviations, non-conformances, and quality events within PV operations.
- Conduct detailed investigations and perform root cause analysis (RCA) using structured methodologies.
- Develop, monitor, and close Corrective and Preventive Actions (CAPAs) within defined timelines.
- Analyze QMS-related data trends and generate insights for continuous improvement.
- Work with dashboards (such as Power BI) to track metrics, validate data accuracy, and support reporting requirements.
- Assist in preparing audit documentation and supporting internal as well as external inspections.
- Act as a subject matter expert (SME) in pharmacovigilance quality standards including GVP, GCP, and GMP.
- Collaborate with cross-functional teams and third-party vendors to ensure compliance and process consistency.
- Identify recurring issues and contribute to process improvement initiatives across global PV operations.
- Maintain high standards of data integrity across safety databases and documentation systems.
- Escalate critical PV issues to management and ensure timely resolution.
- Support documentation updates, SOP reviews, and process mapping activities.
Eligibility Criteria
🎓 Education
Candidates must have one of the following qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related discipline
- Equivalent industry experience in pharmacovigilance or drug safety
💼 Experience
- Minimum 3–5 years of hands-on experience in pharmacovigilance case processing
- At least 1–2 years of experience in quality management systems (QMS)
- Exposure to CAPA management, deviation handling, and audit support is essential
🛠 Skills Required
- Strong understanding of global PV regulations such as FDA, EMA, and ICH guidelines
- Practical knowledge of risk assessment and quality issue management
- Experience in CAPA lifecycle management and compliance tracking
- Familiarity with pharmacovigilance systems like Argus and Veeva Vault Safety
- Proficiency in data analysis tools, especially Power BI
- Excellent documentation and reporting skills
- Strong communication and stakeholder management abilities
- Ability to manage multiple projects and meet deadlines
- Knowledge of SOP creation, review, and process optimization
- Understanding of clinical trial safety and post-marketing surveillance
Salary & Benefits
- Compensation: As per company norms
- Additional benefits may include remote work flexibility, exposure to global pharma projects, and career growth opportunities in pharmacovigilance QA.
Selection Process
The hiring process may include:
- Application screening
- Technical or functional interview
- HR discussion
- Final selection and onboarding
How to Apply
Interested candidates can apply through the official online application portal of the company.
- Apply using your professional resume
- LinkedIn profile submission option may also be available
Important Dates
- Application Start Date: Already Open
- Last Date to Apply: Not specified (apply as early as possible)
Why Apply for This Pharma Job?
This is an excellent opportunity for pharmacovigilance professionals looking to advance their careers in quality assurance and global safety systems. The role offers exposure to international regulatory frameworks and allows professionals to work remotely from India while contributing to high-impact global projects.
Candidates will gain hands-on experience in QMS, CAPA management, audits, and risk assessment, making this role ideal for those aiming to grow into leadership positions in pharmacovigilance and compliance.
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform. We do not directly recruit or charge any fees for job applications. Candidates are advised to verify job details on the official company website before applying.
Final Call-to-Action
If you have experience in pharmacovigilance and quality systems, this remote opportunity can significantly boost your career growth. Apply now to be part of a global pharmaceutical project and enhance your expertise in PV operations and compliance.
