Are you a life sciences graduate looking to kickstart or advance your career in pharmacovigilance? PharmaQuant, a leading healthcare consulting firm specializing in health economics and pharmacovigilance services, is hiring for Trainee Analyst and Junior Analyst roles in Pharmacovigilance. These positions offer an exciting opportunity to work with international pharmaceutical clients, ensuring global drug safety and regulatory compliance. Whether you’re a fresh graduate eager to learn or a professional with 1–2 years of experience in ICSR processing, PharmaQuant provides a dynamic, learning-driven environment to grow your expertise in drug safety, MedDRA coding, and safety database management. Join a collaborative team dedicated to patient safety and regulatory excellence—apply today!
Responsibilities of Trainee Analyst – Pharmacovigilance
As a Trainee Analyst in Pharmacovigilance at PharmaQuant, you’ll work under close supervision to gain hands-on experience in key drug safety activities. Your responsibilities will include:
- Training & Onboarding: Complete structured training on pharmacovigilance principles, global regulatory guidelines (ICH, FDA, EMA, MHRA), safety databases (Argus, ARISg), and MedDRA coding.
- Case Processing Support: Assist in Book-In, data entry, MedDRA/WHO-DD coding, narrative writing, and quality checks for Individual Case Safety Reports (ICSRs) while adhering to strict timelines.
- Literature Surveillance: Review scientific journals for adverse events and extract relevant data for case assessments.
- Documentation & Compliance: Maintain records per Good Vigilance Practice (GVP) standards, follow SOPs, and support audit readiness and CAPA activities.
- Cross-Functional Collaboration: Work with safety physicians, case processors, and other teams to ensure compliant and timely case submissions.
Responsibilities of Junior Analyst – Pharmacovigilance
As a Junior Analyst with 1–2 years of experience, you’ll support end-to-end pharmacovigilance processes with greater independence. Your duties will include:
- ICSR Processing: Perform accurate and timely entry, review, and processing of ICSRs from spontaneous, literature, clinical trial, and solicited sources. Assess seriousness, expectedness, and causality per regulatory guidelines.
- MedDRA Coding & Narrative Writing: Ensure precise MedDRA coding for adverse events, indications, and medical history. Author case narratives and validate data per SOPs.
- Quality & Compliance: Conduct quality control checks and ensure timely submissions to global regulatory authorities (ICH E2B, FDA, EMA, MHRA). Adhere to SOPs and work instructions.
- Literature & Signal Support: Screen scientific journals for adverse events and assist in tracking safety signals or process deviations.
- Stakeholder Collaboration: Coordinate with internal teams (Book-In, Medical Reviewers) and external partners (CROs, licensing partners) for case follow-up and reconciliation.
- System Proficiency: Use validated safety databases (Argus, ARISg, Veeva Vault Safety) for case management and compliance tracking.
Qualifications
Trainee Analyst
- Education: B. Pharm, M. Pharm, M.Sc. Biosciences, any life sciences graduate/postgraduate, Doctorate in life sciences, BDS, MDS, BAMS, or BHMS.
- Experience: Fresh graduates (0–2 years since graduation).
- Skills:
- Basic knowledge of pharmacovigilance or clinical research.
- Familiarity with medical terminology, clinical trials, or regulatory affairs (preferred).
- Proficiency in MS Office (Excel, Word, PowerPoint).
- Exposure to safety databases or MedDRA coding is a plus but not mandatory.
Junior Analyst
- Education: Same as Trainee Analyst.
- Experience: 1–2 years of hands-on experience in pharmacovigilance, specifically ICSR case processing.
- Skills:
- Strong understanding of ICSR workflows, regulatory timelines, and pharmacovigilance processes.
- Proficiency in MedDRA coding and WHO Drug Dictionary.
- Excellent analytical skills, attention to detail, and data entry accuracy.
- Strong communication, organizational, and time management skills.
- Ability to work independently, in teams, and in rotational shifts.
- Proactive problem-solving and commitment to staying updated with industry trends.
Benefits of Joining PharmaQuant
PharmaQuant offers a competitive and rewarding work environment for both roles, including:
- Structured Training & Mentorship: Gain hands-on experience under expert guidance in global pharmacovigilance systems.
- Career Growth: Progress into advanced roles like case processing, subject matter expert (SME), or regulatory positions.
- Competitive Compensation: Receive a stipend/salary aligned with industry standards (Trainee) or performance-linked bonuses (Junior Analyst).
- Certifications: Earn a training completion certificate (Trainee) or access certifications and workshops (Junior Analyst).
- Collaborative Culture: Work in an inclusive, learning-driven environment with opportunities for internal mobility.
- Global Exposure: Engage with international clients and cutting-edge safety databases like Argus and Veeva Vault Safety.
How to Apply
Ready to start your career in pharmacovigilance with PharmaQuant? Email your resume (in PDF or Word format only) to recruitment@pharmaquant.org. Ensure your application highlights relevant qualifications, experience, and your passion for drug safety. Applications are reviewed on a rolling basis, so apply early!
