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    Health (Pharmacovigilance)

 

  • Legal support for the pharmacovigilance (Pv) operations relating to all aspects of clinical safety and risk management, throughout the lifecycle of multiple products and programs, both during development and post-marketing.

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  • Edited aggregate safety documents, including new drug applications (NDAs) and marketing authorization applications (MAAs), submission safety documents, periodic reports and responses to regulatory questions, in close collaboration with Pv operations, clinical development and science, clinical operations, regulatory affairs, quality assurance, medical affairs, medical information and external partners.

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  • Domestic and international Pv policies and procedures that align with prevailing US Food and Drug Administration (FDA), European Union (EU), and other applicable domestic and international regulations.

 

  • Edited and contributed to safety sections of clinical investigator brochures, protocols, core safety information, labels and regulatory reports, periodic safety update reports (PSURs), development safety update reports (DSURs), periodic adverse drug experience reports (PADERs), investigational new drug (IND) reports, suspected unexpected serious adverse reaction (SUSAR) reports, integrated summary of safety, summary of clinical safety, pharmacovigilance system master file (PSMFs), risk management plans (RMPs) and various other reporting documentation, as required.

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  • Familiarity with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Medical Dictionary for Regulatory Activities (MedDRA) coding.

 

  • Safety regulations for both marketed and investigational products and global health authority requirements pertaining to drug safety and risk management, including the Code of Federal Regulations Title 21 (CFR 21), Food and Drug Administration Amendments Act (FDAAA), and EU Good Pharmacovigilance (GVP) Modules.

 

  • Provided strategic legal and tactical support and oversight of all legal aspects of Pv and risk management activities through all stages of clinical development (Phase I-IV) as well as post-marketing patient safety.

 

  • Provided legal oversight for the safety sections of all regulatory documents, including biologics license applications (BLAs), EU Risk Management Plans, EU radioactivity environmental monitoring (REM) plans, International Classification of Functioning, Disability and Health (ICF) framework, presentations, scientific articles and abstracts.

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  • Consultation for off-label-use of medical devices and drugs as well as named patient programs (NPPs) and compassionate use programs (CUPs).

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  • Familiarity with the EU Pv-related legislation, such as Directives – 2001/83/EC, 2003/63/EC, 2004/24/EC, 2004/27/EC, 2010/84/EU, 2012/26/EU – Guidelines – Pharmacovigilance Fees Payable To The European Medicines Agency (EMA) (2012), Good Pharmacovigilance Practices (GVP) (2019) – Statutes – S.I. No. 272 of 2012 (Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2012), S.I. No. 273 of 2012 (Medicinal Products (Control of Manufacture) (Amendment) Regulations 2012), S.I. No. 274 of 2012 Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2012) – and Regulations – (EC) No. 726/2004, (EU) No. 1235/2010, Commission Implementing Regulation No. 520/2012 of 19 June 2012, (EU) No 1027/2012.

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  • Review of international pharmacovigilance agreements (PvAs) between a marketing authorization holders (MAHs) and a third-parties (with which the MAH has shared activities regarding or impacting pharmacovigilance for a particular enterprise), outlining the respective Pv responsibilities of each party during the terms of such enterprises.​

 

  • Negotiation, drafting and management of PvAs.

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  • Participation in Pv strategic planning with the global Pv and ethics (GPv&E) review committee.

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  • Ensured project compliance with Pv requirements in PvAs.

 

  • Managed the assembly and maintenance of PvA data collection and tracking systems.

 

  • Managed all PvA documentation, such as active PvAs, archived PvAs, PvA implementation notifications, PVA templates and terminated PvAs, as well as continued maintenance of the PvA database.

 

  • Responsible for initiating PvA implementation checklists.

 

  • Implemented possible improvements in productivity and quality standards for PvA-related deliverables.

 

  • Participated in actions to mitigate or solve situations of non-compliance with PvA requirements.

 

  • Legal support for the development of PvA process flows and work practices to improve PVA-related systems.

 

  • Conducted analysis of data, gathered critical information, effectively assessed the available team resources, and then provided quality solutions to critical Pv tasks.

 

  • Provided responses to Pv audits, corrective and preventive action plans (CAPAs) and inspections.

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  • Direct interaction with quality assurance and quality control (QA/QC) management and personnel regarding bioanalytics Pv issues.

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  • Supported Pv due diligence activities and managed the database of PvAs.

 

  • Legal support for the continuing assessment of the product safety status.

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  • Formulation of Pv risk evaluation and mitigation strategies (REMSs).

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  • Close coordination with domestic and international scientists and safety physicians to support the evaluation of safety information during clinical development and post-marketing, and to provide proactive risk management strategies.

 

  • Partnered with the clinical development, regulatory and commercial teams to provide all required legal advice.

 

  • Managed the legal review and input of medical information into reports, filings, presentations and publications associated with serious adverse events from clinical trials and post-marketing adverse events and attendance at internal and external meetings.

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  • Advised on regulatory requirements for clinical trials, drug distribution, export issues, good clinical practice (GCP), good documentation practice (GDP), good manufacturing practice (GMP), import issues, market data exclusivity, marketing authorizations, mobile health apps, telemedicine systems.

 

  • Domestic and international compliance for medical devices, distribution and vigilance issues. 

 

  • Advised on product recalls with representation in product liability litigation, settlement negotiations and unfair competition litigation.

 

  • Consultation regarding advertising for drugs and medical devices.

 

  • Consultant for organizational Pv compliance, and the establishment of company-wide compliance programs.

 

  • Advised on various legal aspects of market access, pricing and reimbursement for drugs and medical devices.

 

  • Internal investigations in cases involving suspected anti-corruption issues and suspected violations of regulatory and privacy requirements for clinical trials.

 

  • Consultation in proceedings involving distribution of counterfeited and defective medical devices and products.

 

  • Consultation for a domestic medical devices manufacturer in the acquisition of an international medical devices distribution company.

 

  • Regulatory and compliance due diligence for complex transactions, mergers and acquisitions (M&A) and initial public offerings (IPOs).

 

  • Consultation for life science entities regarding U.S. Food and Drug Administration (FDA) compliance and enforcement matters, such as FDA inspections and pharmacovigilance obligations.

 

  • Legal assistance for preparing an international manufacturing site for an FDA inspection, and worked with a domestic facility in response to FDA inspectional observations (Form FDA 483).

 

  • Consultant for GMP assessments and investigations for pharmaceutical, biotech, and cosmetic companies.

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  • Tracked evolving Pv domestic and international regulatory guidelines related to safety reporting.

 

  •  Provided reports to management on impact of changing Pv regulations and influences on safety data.

 

  • Assisted in the design and implementation of a bioanalytics department testing plan to track manufacturing support needs and product release schedules.

 

  • Monitored and supported management of various bioanalytics department projects.

 

  • Ensured good laboratory practice (GLP) management of objectives, aligned with the project execution plan.

 

  • Knowledge of the advanced analytical and bioanalytical testing methods used in assigned projects, such as biochemical assays, enzyme-linked immunoassay (ELISA), fluorescence-activated cell sorting (FACS), gene expression profiling by reverse transcription quantitative polymerase chain reaction (RT-qPCR) and RNA-seq, quantitative polymerase chain reaction (qPCR) for biodistribution of gene therapy vectors and cell therapy products, and Western Blots.

 

  • Provided Pv and risk management expertise to internal project teams and to external customers.

 

  • Maintained knowledge of the assigned product, the product environment, the product safety issues and the relevant recent literature concerning the product.

 

  • Legal support for cross-functional product safety management teams and safety analysis teams.

 

  • Negotiation and drafting of the legal aspects of clinical development documents, such as clinical development plans, data monitoring plans, integrated summary of safety, investigator brochures, labeling, safety action plans, study protocols, study reports and summary of clinical safety.

 

  • Provided responses to questions from ethics committees, external partners, health authorities and institutional review boards (IRBs).

 

  • Tracked a database of product safety alerts.

 

  • Legal support for the signal detection and data mining center of excellence and for the epidemiology safety group.

 

  • Worked with subject matter experts (SMEs) to identify and implement safety analysis strategies.

 

  • Assisted with safety data review activities and tracked the impact of safety surveillance activities.

 

  • Legal support for the development of Pv safety action plans.

 

  • Responsible for accurate risk communication, such as for advertising, product labeling and promotions.

 

  • Developed product risk management strategies and then monitored their effectiveness.

 

  • Close collaboration with the risk management center of excellence and for epidemiology safety.

 

  • Identification and implementation of risk mitigation opportunities and other corrective actions.

 

  • Monitored the effectiveness of various Pv risk mitigation tools and provided reports to management.

 

    Last updated 210509_1558

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