PharmaLex
Website:
pharmalex.com
Job details:
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Details
The
Senior Specialist, Pharmacovigilance System serves as the strategic and operational bridge between the Pharmacovigilance (PV) business/operations teams and the technical organization. This individual acts as the
system champion, business representative, and end-to-end accountability owner for one or more pharmacovigilance platforms and integrated solutions — ensuring these systems meet regulatory, operational, and quality standards throughout their lifecycle.
This is a highly cross-functional role that requires a unique blend of deep PV domain expertise, systems thinking, stakeholder management, and a forward-looking understanding of emerging technologies including AI. This person ensures those technical workstreams are effectively directed and aligned to business needs.
Key Responsibilities
System Ownership and Governance
- Serve as the 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 new feature rollouts in alignment with business strategy and regulatory requirements
- Lead and manage system lifecycle activities — from business requirements definition, UAT, deployment, through to retirement — ensuring timely and quality delivery of all system milestones
- Maintain and govern all business-owned system documentation, including Business Requirements Documents (BRDs), functional specifications, SOPs, user guides, and validation plans (in close collaboration with validation/QA teams)
- Drive business sign-off and acceptance for all system changes, releases, and validation activities
Business–IT Liaison and Stakeholder Management
- Act as the primary point of contact for all system-related matters between PV Operations, Medical Affairs, Regulatory, Quality Assurance, and the Technical/IT organization
- Translate complex business and regulatory needs into clear, actionable technical requirements for IT developers and vendors
- Facilitate regular forums, governance meetings, and working groups to ensure alignment across business and technical stakeholders
- Manage relationships with external system vendors and platform providers, including participating in vendor performance reviews, roadmap discussions, and contract input where applicable
- Escalate risks, issues, and decisions through appropriate channels with clear business impact framing
System Champion and Change Enablement
- Serve as the internal ambassador for PV systems — promoting best practices, driving adoption, and advocating for user-centric design
- Lead change management efforts for system rollouts and upgrades, including communication planning, training coordination, and stakeholder engagement
- Represent the PV systems landscape in cross-functional forums, steering committees, and process improvement initiatives
- Champion the adoption of innovative technologies — including AI/ML-assisted capabilities — within the PV ecosystem, evaluating feasibility and business value in partnership with IT
Compliance, Quality & Regulatory Alignment
- Ensure all systems under ownership comply with applicable global regulatory frameworks, including ICH E2B(R3), EMA EVMPD, FDA requirements, and GVP modules
- Collaborate with Quality Assurance to ensure systems are maintained in a validated state in accordance with GAMP 5, 21 CFR Part 11, and EU Annex 11
- Support and participate in internal and external audits and regulatory inspections related to PV systems
- Monitor the regulatory landscape and proactively identify impacts to systems from evolving guidance, communicating these to relevant stakeholders
- Ensure data integrity, traceability, and audit trail standards are upheld across all system interactions
Operational Performance & Continuous Improvement
- Define, track, and report on system KPIs and performance metrics, driving continuous improvement initiatives based on operational data
- Identify and implement process optimizations at the intersection of business workflows and system capabilities
- Support business continuity planning related to system downtime, data recovery, and disaster recovery scenarios
- Contribute to strategic planning for the PV systems portfolio, including build/buy/partner evaluations and technology investment recommendations
Required Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, Health Informatics, or a related field; Master's degree preferred
- 3–5 years of experience in Pharmacovigilance, Drug Safety, or a closely related discipline
- 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
Key Skills and Competencies
Business and Stakeholder Skills
- Exceptional cross-functional communication — able to speak both "business" and "technology" fluently
- 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 — able to assess complex problems and drive solutions
- Skilled in requirements gathering, business process mapping, and gap analysis
- Effective vendor management and negotiation capabilities
- Comfortable presenting to and engaging senior leadership
Personal Competencies
- Detail-oriented with a quality-first mindset
- Proactive, self-directed, and comfortable operating with ambiguity and autonomy
- Collaborative and empathetic — a natural team enabler and culture carrier
- Adaptable to a rapidly evolving technology and regulatory landscape
- Demonstrates integrity and accountability, especially in a patient safety context
Technical Knowledge Requirements
PV Safety Databases & Case Management
- Hands-on familiarity (business user level) with leading safety databases.
- Understanding of E2B(R3) case data structure, ICSR processing workflows, MedDRA coding, and regulatory submission timelines (e.g., 7/15-day reporting)
Reporting & Analytics Tools
- Experience with PV reporting platforms and dashboards, Power BI or equivalent BI tools for operational metrics CIOMS and PSUR/PBRER report generation workflows
- Ability to define and validate KPI reporting requirements in collaboration with data teams
Signal Detection & Management Tools
- Familiarity with signal management platforms.
- Understanding of disproportionality analysis (PRR, ROR, EBGM) and signal workflow from detection through evaluation and escalation
- Knowledge of EudraVigilance and FDA FAERS database structures and access
Literature Monitoring & Search Tools
- Experience with or oversight of systematic literature search tools.
- Understanding of ICSR extraction from literature, deduplication, and integration with safety databases.
- Awareness of AI-powered literature monitoring solutions and automation capabilities in this space
Artificial Intelligence and Emerging Technologies
- Awareness of AI/ML applications in pharmacovigilance, including: AI-assisted case narrative generation and MedDRA auto-coding NLP for literature monitoring and social media surveillance Predictive analytics for signal detection and risk assessment Large Language Models (LLMs) and their responsible 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 (data lineage, explainability, auditability)
Data and Integration Knowledge
- Understanding of PV data flows and system integrations (e.g., CRO feeds, affiliate submissions, E2B gateway connections)
- Familiarity with HL7, FHIR, 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 (not hands-on, but enough to direct and review)
Regulatory & Quality Frameworks
- Solid knowledge of GVP Modules (especially I, V, VI, VIII, IX, XVI)
- Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and CSV/CSA (Computer Software Assurance) principles
- Familiarity with ICH E2A, E2B, E2C, E2D, E2E guidelines
- Understanding of audit trail requirements, data integrity standards (ALCOA+), and inspection readiness
Bachelor's degree in life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related field, or equivalent experience required. 4+ years of experience in pharmacovigilance, drug safety, epidemiology, risk management, scientific consulting, regulatory affairs, or a related field required. Certification in pharmacovigilance, drug safety preferred. Certification in regulatory affairs, clinical safety preferred. Certification in quality management, auditing preferred.
What Cencora offers
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full time
Affiliated Companies
Affiliated Companies: PharmaLex India Private Limited
Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
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