QPI Expert (Quality + Pharmacovigilance)
Productlife Group · Ahmedabad · onsite · Posted 64d ago
Undisclosed2–7 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Data Officer (IN)
ProductLife Group (PLG) is a global consulting and outsourcing company supporting life sciences organizations throughout the product lifecycle.
- Perform triage, review, and data entry of pharmacovigilance cases.
- Process and maintain Individual Case Safety Reports (ICSRs) in accordance with applicable regulations and internal procedures.
- Support the submission of ICSRs to health authorities, clients, and partners.
- Manage and monitor assigned pharmacovigilance mailboxes.
- Follow up directly with consumers, patients, healthcare professionals, and other stakeholders to obtain missing safety information when required.
- Perform XEVMPD (Extended EudraVigilance Medicinal Product Dictionary) related activities.
- Ensure data accuracy, completeness, and consistency across safety databases.
- Maintain compliance with quality standards, SOPs, and regulatory requirements.
- Collaborate effectively with cross-functional teams and stakeholders.
- Support continuous improvement initiatives and operational excellence activitie
Required Education
- Bachelor s degree in Life Sciences, Pharmacy, Biotechnology, Biology, or a related scientific discipline.
- Minimum 2 years of experience in pharmacovigilance data entry within a post-marketing environment.
- Experience handling and processing ICSRs.
- Proven experience with XEVMPD activities .
- Excellent written and verbal communication skills in English .
- Additional languages are considered an asset.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).
- Strong attention to detail and data accuracy.
- Excellent organizational and time-management skills.
- Process-oriented mindset.
- Ability to work effectively in a team environment.
- Flexibility and adaptability in a fast-paced setting.
- Experience working with pharmacovigilance databases.
- Knowledge of regulatory pharmacovigilance requirements.
- Previous exposure to safety database management systems.
- Additional experience with XEVMPD maintenance and data management.
- Database experience is preferred; training will be provided where needed.
- Attention to Detail
- Customer Focus
- Accountability
- Teamwork and Collaboration
- Communication Skills
- Problem Solving
- Planning and Organization
- Quality Orientation
Disclaimer: This job posting & Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
pharmacovigilanceConsultingContinuous improvementOutsourcingOperational ExcellenceHealthcareData ManagementData EntryLife Sciences