IQVIA is hiring for the position of Operations Specialist – 1 – Japanese in Pune, Maharashtra. This opportunity is suitable for candidates from scientific, healthcare, and allied life sciences disciplines who want to build or advance their careers in pharmacovigilance, drug safety, adverse event processing, and safety case management.
The Operations Specialist will review, assess, and process safety information received from different sources while ensuring compliance with applicable regulations, Standard Operating Procedures (SOPs), client requirements, and internal guidelines.
The role involves hands-on pharmacovigilance activities such as adverse event processing, safety database entry, medical coding, narrative writing, literature activities, and case tracking.
Key Responsibilities
Selected candidates may be responsible for:
- Processing safety and pharmacovigilance data according to applicable regulations, SOPs, and project requirements.
- Collecting and tracking incoming Adverse Event (AE) and endpoint information.
- Determining whether incoming safety information represents an initial or follow-up case.
- Performing safety database entry and maintaining case information.
- Coding adverse events and medicinal products.
- Writing clear and accurate safety case narratives.
- Supporting pharmacovigilance literature-related activities.
- Creating, maintaining, and tracking safety cases according to project requirements.
- Meeting established quality, productivity, and delivery standards.
- Identifying quality issues and escalating them to senior team members.
- Working with project management, clinical, data management, investigators, medical monitors, and site coordinators.
- Communicating with clients regarding day-to-day case-processing activities when required.
- Participating in project meetings and providing operational feedback.
- Supporting departmental initiatives and mentoring newer team members when assigned.
- Reviewing non-serious AEs and ADRs where required, including AE coding, medical history, concomitant medications, expectedness/listedness, causality, and other medical information.
- Maintaining compliance with IQVIA and customer SOPs and completing assigned training within required timelines.
Qualifications
Candidates should have:
- Bachelor’s degree in a scientific, healthcare, or allied life sciences discipline.
- Bachelor’s degree with up to 3 years of relevant experience, or an equivalent combination of education, experience, and training.
- Good knowledge of medical terminology.
- Working knowledge of safety databases and related applications.
- Knowledge of global, regional, and local clinical research regulatory requirements.
- Strong attention to detail and commitment to data quality.
- Good Microsoft Office and web-based application skills.
- Strong organizational and time-management abilities.
- Good written and verbal communication skills.
- Ability to work independently and follow established guidelines.
- Ability to manage multiple priorities and strict deadlines.
- Willingness to learn skills across different Safety service lines.
- Ability to work effectively with team members, managers, and clients.
- Flexibility to work in shifts.
- Willingness to travel occasionally if required.
Relevant educational backgrounds may include: Pharmacy, Pharmaceutical Sciences, Pharm.D, Life Sciences, Biotechnology, Microbiology, Biochemistry, Nursing, Medicine, Dentistry, Clinical Research, Biomedical Sciences, and other scientific or healthcare-related disciplines, subject to IQVIA’s assessment of the candidate’s degree.
Key Skills
Pharmacovigilance | Drug Safety | Adverse Event Processing | AE/ADR | Safety Case Processing | Safety Database | Medical Coding | Narrative Writing | Literature Review | Medical Terminology | Case Management | Regulatory Compliance | SOP Compliance
Why Consider This Opportunity?
This IQVIA pharmacovigilance job provides exposure to global drug safety operations and structured safety case-processing activities. Candidates can gain experience working with safety databases, adverse event information, narratives, coding, regulatory requirements, SOPs, and multidisciplinary clinical research teams.
The position may be particularly relevant to early-career life sciences professionals seeking experience in pharmacovigilance and drug safety operations.
How to Apply
