Kelly Benner Email & Phone Number

Princeton, New Jersey, United States

Horsham, Pa

Lead efforts to ensure new/revised/emerging global pharmacovigilance (PV) regulations are identified, tracked and assessed for local and global impact to the Global Medical Organization (GMO) and other internal stakeholders, by acting as key liaison to GMO and other departments, leading cross-functional gap assessments, driving commenting activities, interpreting new requirements, offering innovative solutions and recommendations, assessing risk, and benchmarking. Ensure global alignment and… Show more Lead efforts to ensure new/revised/emerging global pharmacovigilance (PV) regulations are identified, tracked and assessed for local and global impact to the Global Medical Organization (GMO) and other internal stakeholders, by acting as key liaison to GMO and other departments, leading cross-functional gap assessments, driving commenting activities, interpreting new requirements, offering innovative solutions and recommendations, assessing risk, and benchmarking. Ensure global alignment and compliance to PV regulation by Local Safety Offices and key internal/external stakeholders. Represent Janssen and Janssen’s interests with external stakeholders on PV-specific regulatory topics. Influence the external environment regarding PV regulation. Manage a PV intelligence network, supporting industry association connection. Provide project management for high-complexity implementation of new/revised PV regulatory requirements within GMO. Lead and participate in internal working groups as needed. Show less

Plainsboro, Nj

Led US Pharmacovigilance Case Handling Operations Team consisting of 45+ Safety Professionals processing 50k+ Individual Case Safety Reports (ICSRs) annually (receipt, assessment, processing, coding, medical review, and regulatory submission) and technical / product quality complaints for clinical and post-marketed products (drugs and devices). US PV Operations lead and primary point of contact for FDA PV inquiries, as well as product recalls, stolen / counterfeit / diverted product… Show more Led US Pharmacovigilance Case Handling Operations Team consisting of 45+ Safety Professionals processing 50k+ Individual Case Safety Reports (ICSRs) annually (receipt, assessment, processing, coding, medical review, and regulatory submission) and technical / product quality complaints for clinical and post-marketed products (drugs and devices). US PV Operations lead and primary point of contact for FDA PV inquiries, as well as product recalls, stolen / counterfeit / diverted product, and global regulation changes, requiring daily collaboration with Global Safety, Regulatory Affairs, Legal, Compliance, Medical Information, Clinical Trial Management, Product Supply, Quality, Sales and Marketing. Show less

Parsippany, Nj

Led global team of 15 Operations & Logistics professionals ensuring contractual agreements include appropriate PV language compliant with global PV requirements. Managed PV budget, resource planning, job descriptions, site services and document storage. As an ad-interim Compliance Head, managed global team of 10 Compliance professionals partnering with EU-QPPV to ensure compliance with global regulations, policies and guidelines (includes NCH line functions and EU Affiliates), oversaw… Show more Led global team of 15 Operations & Logistics professionals ensuring contractual agreements include appropriate PV language compliant with global PV requirements. Managed PV budget, resource planning, job descriptions, site services and document storage. As an ad-interim Compliance Head, managed global team of 10 Compliance professionals partnering with EU-QPPV to ensure compliance with global regulations, policies and guidelines (includes NCH line functions and EU Affiliates), oversaw local and global PV processes and provided training, tracked global metrics, facilitated internal / external audits / inspections, managed CAPAs.Created and implemented global process (central + 75+ affiliates) for development and maintenance of global PV Agreements including global templates and affiliate support for local agreements; collaborated with multiple functions (e.g. Legal, BD&L, QA, GRA, Export Operations) and Novartis Sectors (e.g. Novartis Pharma, Sandoz, Alcon) to ensure cross-functional alignment.Created, revised and maintained standard adverse event language for all Master Agreements, QA Agreements, Protocols, and Investigator Initiated Studies.NCH PV lead for multiple and cross-sector initiatives: PV Process Re-engineering; Outsourcing / Offshoring Project; R&D Career Development Initiative; Sunshine Law Implementation; Implementation of EU GVP modules.Re-engineered rapidly growing global PV department using Process Improvement Process in collaboration with external consultant. Show less

Parsippany, Nj

Led global team of 15 Operations & Logistics professionals ensuring contractual agreements include appropriate PV language compliant with global PV requirements. Managed PV budget, resource planning, job descriptions, site services and document storage. Created and implemented global process (central + 75+ affiliates) for development and maintenance of global PV Agreements including global templates and affiliate support for local agreements; collaborated with multiple functions (e.g… Show more Led global team of 15 Operations & Logistics professionals ensuring contractual agreements include appropriate PV language compliant with global PV requirements. Managed PV budget, resource planning, job descriptions, site services and document storage. Created and implemented global process (central + 75+ affiliates) for development and maintenance of global PV Agreements including global templates and affiliate support for local agreements; collaborated with multiple functions (e.g. Legal, BD&L, QA, GRA, Export Operations) and Novartis Sectors (e.g. Novartis Pharma, Sandoz, Alcon) to ensure cross-functional alignment.Created, revised and maintained standard adverse event language for all Master Agreements, QA Agreements, Protocols, and Investigator Initiated Studies.NCH PV lead for multiple and cross-sector initiatives: PV Process Re-engineering; Outsourcing / Offshoring Project; R&D Career Development Initiative; Sunshine Law Implementation; Implementation of EU GVP modules.Re-engineered rapidly growing global PV department using Process Improvement Process in collaboration with external consultant. Show less

Jersey City, Nj

Developed, maintained and ensured compliance to all DSS processes, procedures and contractual obligations including SOPs, Working Documents, Guides, Job Aids and PV Agreements. Oversight of required process changes due to updates to new regulations, laws, guidances, and corporate decisions. Recruited, trained and developed all DSS staff (50+), including mentorship of people managers.

Jersey City, Nj

Managed team of 8+ Drug Safety Associates responsible for receipt (phone, fax and email), triage, assignment, processing (data entry, COSTART / MedDRA coding, narrative writing), and submission / follow-up of ICSRs for clinical trial and post-marketing adverse events for all products. Partnered with Director and external consultant to build and re-engineer DSS department from 4 to 50+ FTEs (40+ in NY / NJ and 10+ in fully operational, independent satellite in St. Louis, MO).Migrated… Show more Managed team of 8+ Drug Safety Associates responsible for receipt (phone, fax and email), triage, assignment, processing (data entry, COSTART / MedDRA coding, narrative writing), and submission / follow-up of ICSRs for clinical trial and post-marketing adverse events for all products. Partnered with Director and external consultant to build and re-engineer DSS department from 4 to 50+ FTEs (40+ in NY / NJ and 10+ in fully operational, independent satellite in St. Louis, MO).Migrated safety database from ARISg to Clintrace.Managed all potential litigation cases and oversaw compliance with all internal / external KPIs. Primary DSS point-of-contact for all non-DSS functions (e.g. clinical, medical, regulatory, manufacturing, sales, marketing, quality) and to resolve issues with local manufacturing sites.Established and maintained strong working relationships with license partners.Developed and implemented procedures to support growing PV department, (SOPs, organizational charts, regulatory reporting requirement flow diagrams, and Job Aids).Presented at Investigator Meetings and National Sales Meetings. Show less

New York, Ny

Responsible for receipt (phone, fax and email), triage, assignment, processing (data entry, COSTART / MedDRA coding, narrative writing), and submission / follow-up of ICSRs for clinical trial and post-marketing adverse events for all products. Performed reconciliation between clinical and safety databases and prepared aggregate safety reports for all products (US Periodic ADE Reports and safety portion of IND Annual Reports). Primary DSS point-of-contact for all non-DSS functions (e.g… Show more Responsible for receipt (phone, fax and email), triage, assignment, processing (data entry, COSTART / MedDRA coding, narrative writing), and submission / follow-up of ICSRs for clinical trial and post-marketing adverse events for all products. Performed reconciliation between clinical and safety databases and prepared aggregate safety reports for all products (US Periodic ADE Reports and safety portion of IND Annual Reports). Primary DSS point-of-contact for all non-DSS functions (e.g. clinical, medical, regulatory, manufacturing, sales, marketing, quality) and to resolve issues with local manufacturing sites.Developed process for review and tracking of literature articles for adverse events, which was commended by FDA during FDA PV Inspection, and noted as best practice. Show less

New York, Ny

Responsible for receipt (phone, fax and email), triage, assignment, processing (data entry, COSTART / MedDRA coding, narrative writing), and submission / follow-up of ICSRs for clinical trial and post-marketing adverse events for all products.Performed reconciliation between clinical and safety databases and prepared aggregate safety reports for all products (US Periodic ADE Reports and safety portion of IND Annual Reports).

Collegeville, Pa

Responsible for receipt (phone / fax), triage, assignment, processing (data entry, COSTART coding, narrative writing) and follow-up of ICSRs for clinical trial and post-marketing adverse events for oncology products, CNS products, and Fen-Phen (fenfluramine/phentermine) legal cases. Performed reconciliation between clinical and safety databases.

Collegeville, Pa

Responsible for receipt (phone / fax), triage and assignment of clinical trial and post-marketing adverse events for oncology products and CNS products.

Ms, Qa/Ra

Certificate - Medical Devices

Ba, Biology, Medical Humanities, Pre-Medicine

Activities and Societies: Tri-Beta National Biological Honor Society