Senior Specialist, Pharmacovigilance System

Job not on LinkedIn

🔥 3 hours ago

🌐 India, Bulgaria – Remote

🇮🇳 India – Remote 🇧🇬 Bulgaria – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Cencora

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

Cencora is a company dedicated to improving the health and well-being of both people and animals globally. Built on the legacy of AmerisourceBergen, Cencora offers a wide range of industry-leading solutions that encompass specialty logistics, warehousing, drug research, clinical development support, and more. They provide commercialization and patient access support and offer wholesale and specialty distribution services. Cencora serves a diverse clientele, including pharmaceutical companies, physician practices, pharmacies, and health systems. The company also extends its services to animal health, managing operations and delivering products for animal pharmaceutical care. With a strong global footprint, Cencora aims to reshape healthcare delivery through innovative products and solutions, striving to create healthier futures for all.

📋 Description

• Serve as accountable business system owner for PV-related platforms, including safety databases, signal management tools, medical information systems, literature monitoring solutions, and reporting platforms • Own and maintain the system roadmap, prioritizing enhancements, upgrades, and feature rollouts aligned with business strategy and regulatory requirements • Lead system lifecycle activities from business requirements definition and UAT through deployment and retirement • Maintain and govern business-owned system documentation, including BRDs, functional specifications, SOPs, user guides, and validation plans • Drive business sign-off and acceptance for system changes, releases, and validation activities • Act as primary liaison between PV Operations, Medical Affairs, Regulatory, Quality Assurance, and Technical/IT teams • Translate business and regulatory needs into actionable technical requirements for developers and vendors • Facilitate governance meetings, forums, and working groups • Manage external system vendor and platform-provider relationships, including performance reviews, roadmap discussions, and contract input • Escalate risks, issues, and decisions with clear business-impact framing • Promote best practices, system adoption, and user-centric design as the internal PV systems champion • Lead change management for system rollouts and upgrades, including communications, training coordination, and stakeholder engagement • Represent the PV systems landscape in cross-functional forums, steering committees, and process-improvement initiatives • Evaluate and champion AI/ML-assisted capabilities in partnership with IT • Ensure systems comply with global regulatory frameworks including ICH E2B(R3), EMA EVMPD, FDA requirements, and GVP modules • Collaborate with Quality Assurance to maintain validated systems under GAMP 5, 21 CFR Part 11, and EU Annex 11 • Support internal and external audits and regulatory inspections • Monitor regulatory changes and communicate system impacts to stakeholders • Ensure data integrity, traceability, and audit-trail standards • Define, track, and report system KPIs and performance metrics • Identify and implement process optimizations at the intersection of workflows and system capabilities • Support business continuity planning for downtime, data recovery, and disaster recovery • Contribute to PV systems portfolio strategy, build/buy/partner evaluations, and technology investment recommendations

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Health Informatics, or a related field; Master's degree preferred • Bachelor's degree in life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related field, or equivalent experience required • 3–5 years of experience in Pharmacovigilance, Drug Safety, or a closely related discipline • 4+ years of experience in pharmacovigilance, drug safety, epidemiology, risk management, scientific consulting, regulatory affairs, or a related field required • Demonstrated experience owning or managing PV systems or technology platforms in a business capacity • Strong understanding of the end-to-end life science lifecycle, from case intake through aggregate reporting and signal management • Experience working in a regulated GxP environment and with validated systems • Exceptional cross-functional communication and ability to translate between business and technology • Strong project and program management skills; ability to manage multiple system workstreams simultaneously • Proven ability to influence without authority across organizational levels and functions • High-level analytical and critical thinking skills • Skilled in requirements gathering, business process mapping, and gap analysis • Effective vendor management and negotiation capabilities • Comfortable presenting to and engaging senior leadership • Hands-on familiarity with leading safety databases at business-user level • Understanding of E2B(R3) case data structure, ICSR processing workflows, MedDRA coding, and regulatory submission timelines • Experience with PV reporting platforms and dashboards, Power BI or equivalent BI tools, and CIOMS and PSUR/PBRER report generation workflows • Ability to define and validate KPI reporting requirements in collaboration with data teams • Familiarity with signal management platforms and disproportionality analysis (PRR, ROR, EBGM) • Knowledge of EudraVigilance and FDA FAERS database structures and access • Experience with or oversight of systematic literature search tools • Understanding of ICSR extraction from literature, deduplication, and integration with safety databases • Awareness of AI/ML applications, AI-powered literature monitoring, automation, NLP, predictive analytics, LLMs, and responsible AI use in PV workflows • Ability to critically evaluate AI vendor claims and assess technology fit for regulated PV environments • Understanding of AI governance requirements in GxP contexts, including data lineage, explainability, and auditability • Understanding of PV data flows and system integrations, including CRO feeds, affiliate submissions, and E2B gateway connections • Familiarity with HL7, FHIR, and E2B XML data standards • Comfort with data mapping, data quality principles, and working alongside data architects and engineers • Basic understanding of API-based integrations and middleware concepts • Solid knowledge of GVP Modules I, V, VI, VIII, IX, and XVI • Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and CSV/CSA principles • Familiarity with ICH E2A, E2B, E2C, E2D, and E2E guidelines • Understanding of audit trail requirements, ALCOA+ data integrity standards, and inspection readiness • Certification in pharmacovigilance, drug safety, regulatory affairs, clinical safety, quality management, or auditing preferred

🏖️ Benefits

• Benefit offerings outside the US may vary by country and will be aligned to local market practice • Equal employment opportunity and non-discriminatory recruiting, training, compensation, benefits, promotions, and transfers • Reasonable accommodations during the employment process for individuals with disabilities