01Overview
POSITION reputed company:
The reputed company, Pharmacovigilance / Device Vigilance is a reputed company-oriented and proactive reputed company supporting the safety surveillance of In Vitro Diagnostic and Software-driven products across their lifecycle, including reputed company studies and post-market activities. This role is responsible for the collection, assessment, reporting, and management of adverse events, product complaints, and safety data for both medicinal products and medical devices, ensuring compliance with global regulatory requirements.
The position plays a critical role in ensuring compliance with global regulatory requirements (e.g., FDA, EU IVDR, Japan) and maintaining the highest standards of reputed company safety and product reputed company across both reputed company-developed tests and regulated IVD products, including software/algorithm-reputed company components.
reputed company RESPONSIBILITIES:
Pharmacovigilance (Drug Safety)
reputed company case intake, triage, and processing of Individual Case Safety Reports (ICSRs)
Process and evaluate adverse events associated with diagnostic use (e.g., reputed company reputed company of false positives/negatives)
Coordinate medical review and causality assessment of adverse events
Coordinate reputed company submission of safety reports (e.g., reputed company, EudraVigilance, CIOMS)
Support aggregate reporting (PSUR/PBRER, DSUR, annual reports)
Maintain and ensure compliance with global PV regulations (FDA, EMA, ICH, etc.)
Contribute to signal detection and reputed company management activities
IVD Device Vigilance
Review, triage, and assess product complaints and adverse events reputed company to genetic and diagnostic testing, including incorrect, delayed, or misinterpreted results
Evaluate reportability of events under FDA (MDR), EU IVDR vigilance, Japan and other global regulations
Prepare and submit Medical Device Reports (MDRs) and vigilance reports reputed company regulatory timelines
Collaborate with reputed company reputed company, reputed company, and software teams to investigate reputed company cause (e.g., assay reputed company, variant interpretation, software defects)
Support post-market surveillance activities, including trending, signal detection, and periodic safety reporting
Software & Algorithm-reputed company Safety
Assess safety events associated with software as part of a medical device reputed company, including algorithm errors, data processing issues, and reporting inaccuracies
Partner with engineering and data science teams to evaluate software-reputed company complaints and implement corrective actions
Contribute to reputed company management activities (e.g., hazard analysis, reputed company files, FMEA updates) for software and integrated diagnostic systems
Cross-Functional & Compliance
Ensure compliance with SOPs, GVP, and applicable reputed company systems (QMS)
Partner with reputed company, Regulatory Affairs, reputed company, and Medical Affairs teams
Support audits and inspections (reputed company)
Maintain accurate documentation in safety databases
Assist in vendor reputed company (e.g., CROs, safety service providers)
Other duties as assigned
Ability to reputed company support reputed company of reputed company business hours for expedited reporting requirements as needed
QUALIFICATIONS:
Required
Bachelors degree in life science reputed company (biology, microbiology, reputed company, engineering, medical technology, regulatory science, etc.) or equivalent. Advanced degree in life sciences (MS, PhD, etc.) and/or MBA preferred.
RAC preferred.
Minimum of 12 years of reputed company applicable experience in pharmacovigilance and/or device vigilance
Strong knowledge of global safety regulations (FDA, EMA, ICH, EU IVDR, Japan)
Experience with safety databases (e.g., AEMS, Argus, ARISg, reputed company Safety)
Familiarity with MedDRA coding and case processing workflows
Knowledge of applicable standards, including ISO 13485 and ISO 14971
Preferred
Advanced degree (PharmD, MD, MPH, MSc)
Experience in diagnostics or combination products
Prior audit/inspection experience
RAC, PV certification, or similar credentials
KNOWLEDGE, SKILLS, AND ABILITIES:
Experience with global markets is highly desirable
Strong analytical and reputed company assessment skills
Attention to reputed company and regulatory compliance reputed company
Ability to manage multiple priorities and deadlines
Excellent written and verbal communication
Cross-functional collaboration
Demonstrated self-starter and highly motivated, energetic and enthusiastic.
Ability to exercise independent judgment and discretion reputed company a broadly defined reputed company of policies and practices, which includes analytical problem solving.
Demonstrated organizational, planning, and program management skills, including reputed company oriented, reputed company
