Operations Specialist 2 -
Location:
Bengaluru, India
Job Type:
Full-time
Job ID:
R1474048
Job Overview:
IQVIA is seeking an Operations Specialist 2 to apply knowledge and expertise, including complex decision-making activities, to review, assess, and process Safety data across service lines. Recognized as a specialist in one or more areas, you will provide oversight on small to medium service operational projects and act as a mentor to junior staff.
Essential Functions:
Safety Data Processing: Process safety data per applicable regulations, guidelines, SOPs, and project requirements.
Pharmacovigilance Activities: Perform tasks such as collecting and tracking incoming Adverse Events (AE)/endpoint information, determining initial/update status of events, database entry, coding AE and products, writing narratives, literature reviews, quality reviews, reconciliation, and case closure.
Regulatory Reporting: Assess safety data for reportability, track reportable cases, and ensure timely submission to regulatory authorities and other oversight groups.
Vendor & Stakeholder Liaison: Coordinate with internal teams, clients, and regulatory bodies to ensure adherence to project timelines and requirements.
Process Oversight: Lead or contribute to Safety Publishing, Risk Management, Safety Surveillance, and Medical Information deliverables.
Team Leadership & Mentorship: Build a collaborative environment, mentor junior team members, and assist Operations Manager as a backup when required.
Regulatory Compliance: Ensure compliance with project processes, maintain thorough knowledge of project protocols, and ensure audit readiness.
Training & Development: Participate or lead training sessions across Safety processes and identify process improvement opportunities.
Qualifications:
Education: Bachelor's Degree in Scientific, Healthcare, or Allied Life Sciences discipline required.
Experience:
Up to 5 years of relevant experience, including up to 3 years in Pharmacovigilance.
Strong knowledge of medical terminology, safety databases, and applicable global/regional clinical research regulatory requirements.
Technical Skills:
Proficiency in Microsoft Office and web-based applications.
Strong project management, leadership, and mentoring skills.
Communication & Collaboration:
Excellent verbal and written communication skills.
Ability to build and maintain effective working relationships with stakeholders.
Key Competencies:
Self-motivated, flexible, and receptive to changing process demands.
Proven ability to manage multiple projects, meet deadlines, and prioritize tasks effectively.
Strong judgment, decision-making, and negotiation skills.
Commitment to quality, compliance, and audit preparedness.
Additional Information:
Travel: May require occasional travel.
Shifts: Flexibility to operate in shifts is required.
About IQVIA:
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments, improving patient outcomes worldwide.
Learn More: https://jobs.iqvia.com
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