Manager Safety

Janet Gonzalez

** ****** ****, *** *******, NY **553 H: 845-***-**** C: 914-***-**** *******@***.***

Summary

Capable leader with over 18 years of pharmacovigilance in multiple therapeutic areas of human medicines, proven ability to understand the complexity of the safety reporting environment and bring high quality, cost effective solution to operational issues, track record of managing high performing teams and change leadership with strong communication, coaching and people skills. Consistently demonstrated a programmatic approach to the application of both US and EU drug safety regulations

Core Qualifications

Excellent communication skills, organizational skills, and attention to detail

Strong analytical skills

Quality improvement and operations management experience

Strong team and vendor management experience

Effective training, coaching and performance management

Professional Experience

Pharmacovigilance Operations Manager 5/2016-11/2016

United Therapeutics Research Triangle Park, NC

Managed daily operational and adverse event case processing activities for clinical trial and post-marketed products, including medical devices

Provided vendor oversight and management for all outsourced and insourced PV activities, including establishing and monitoring quality and compliance metrics

Oversaw the set-up of new safety projects, including the set-up of database configurations in the PV database to accommodate new studies and products

Represented drug safety as a leader on project teams, with other departments and committees, as needed

Provided performance management, coaching and development for three direct reports

Safety Officer, Global Pharmacovigilance Office, US Drug Safety Unit 9/2008-7/2015

Pfizer Inc. New York, NY

Organized, managed, and actively carried out local pharmacovigilance activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by US Drug Safety Unit, local contractual agreements, process documentation and training, inspection preparedness and any other required country-specific safety activity

Carried out all adverse event case processing activities for clinical trial and post-marketed products including case receipt and triage, data entry, medical coding using MedDRA and WHO-Drug dictionaries, narrative writing, query generation and follow-up activities

Ensured regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents

Provided oversight and team mentoring on case handling aspects, data extraction and analyses

Acted as subject matter expert for the US Drug Safety Unit, suppliers, and stakeholders locally concerning safety-related issues and liaised with key partners (e.g. Business Units, License partners) regarding safety data collection and handling

Provided training and daily oversight to CRO and other vendor staff responsible for adverse event case processing including performing the quality review of individual case reports

Product and Team Support Manager, US Clinical Safety, Safety Evaluation and Reporting

9/2008-11/2010

Acted as a single point of contact for the clinical teams on safety related issues for US investigational products in sponsored clinical trials

Led issue management between the clinical teams and other stakeholders and communicated issues and process changes to the clinical and therapeutic area teams

Coordinated and facilitated communication between the US clinical SAE Case Processing manager and Pfizer divisions including therapeutic area sites, regulatory, licensing, and medical

Managed the distribution process for serious, unexpected adverse reactions originating from Pfizer sponsored clinical trials, non-Pfizer clinical trials and non-clinical trial sources to US investigators participating in Pfizer sponsored clinical trials

Associate Director Medical Safety 3/2007-9/2008

Regeneron Pharmaceuticals Inc. Tarrytown, NY

Managed the daily receipt, collection, processing and reporting of serious adverse events for all investigational products, providing training and oversight of CROs and ensuring the completion of work assignments in accordance with FDA regulations, ICH guidelines, SOPs and working practices

Participated in the development and implementation of post-marketing adverse event reporting SOPs and working practices

Participated in the NDA submission for ARCALYST (rilonacept)

Provided performance management, training, and development for six direct reports

Manager Drug Safety and Surveillance 6/2006-11/2006

Schering Plough Research Institute Kenilworth, NJ

Supported Worldwide Safety Surveillance in the receipt, collection, assessment, processing, and quality review of adverse event reports for investigational and marketed products

Responded to inquiries from Country Operations, Clinical Research, Global Drug Information and other internal colleagues and healthcare professionals

Manager Medical Safety 11/2004-6/2006

Regeneron Pharmaceuticals Inc. Tarrytown, NY

Developed and implemented safety reporting SOPs and internal processes

Received, reviewed, processed, evaluated, and followed up on reports of serious adverse events occurring in clinical trials, phases 1-3, performing and reviewing medical coding using MedDRA and WHO-DD dictionaries and developed procedures for and performed SAE reconciliation

Provided safety reporting training and guidance to investigators, site staff, internal clinical staff and CRO staff

Provided coaching, training, development, and performance management for one direct report

Senior Manager Drug Safety 2/2004-11/2004

Progenics Pharmaceuticals Tarrytown, NY

Managed safety reporting processing for IND clinical trials monitoring safety reporting responsibilities of CROs and other external vendors

Developed cost analysis for an internal safety database and Safety group

Manager Drug Safety 3/2002-2/2004

Yamanouchi Pharma America Paramus, NJ

Assisted in the development of a drug safety function in the US for clinical trial and post-marketed products assisting in the planning and implementation of the global safety database, developing, and implementing SOPs, processes and a document filing system

Reviewed and evaluated serious adverse event reports ensuring compliance with FDA regulations, ICH guidelines and internal SOPs

Prepared IND safety reports for submission to regulatory authorities and assisted in the preparation and review of IND and NDA submission documents

Interviewed, hired, provided training, coaching and performance management for four direct reports

Pfizer Inc. 9/1996-3/2002

New York, NY

Quality Operations Manager

2000-2002

Developed and managed Quality Operations group functions: Quality Control, Quality Assurance, ongoing and end of study case report form/data clarification form review, safety database reconciliation and unblinding of clinical trial safety data

Assisted the Worldwide Clinical teams and Clinical data operations in establishing processes for the review and reconciliation of safety data

Participated in continuous improvement initiatives to redefine and document key processes

Provided coaching, training, and performance management for six direct reports

Serious Adverse Event Resource Group Manager

1999-2000

Managed QC, QA and performance functions and served as a resource for investigational site and CRO personnel

Developed protocol-specific safety reporting procedures

Coordinated and managed the training program for new hires and provided coaching, development and performance management for SAE Coordinators and consultants

Quality Improvement Associate

1998-1999

Developed, implemented, performed, and documented QC review of serious adverse event reports

Complied and analyzed QC data, prepared performance reports, conducted departmental audits and developed and implemented corrective action plans

Serious Adverse Event Coordinator

1996-1998

Performed all adverse event case processing activities for investigational products including case receipt and triage, case assessment, data entry, medical coding using MedDRA and WHO-Drug dictionaries, narrative writing, query generation, quality review and follow-up activities

Trained investigators and CRO staff on serious adverse event reporting procedures and collaborated with clinical project managers, study managers and clinicians in setting up safety reporting

Performed case report form and data clarification form review for safety data and performed serious adverse event reconciliation

Education

Bachelor of Science, Organizational Management

Nyack College Nyack, NY

Associates Applied Science

Rockland Community College Suffern, NY

New York State Registered Nurse

Skills

Computer Skills: Microsoft Office, Safety Databases: Adverse Event Monitoring (AEM), ARISg, ClinTrace, Adverse Event Reporting System (AERS), Argus

Contact this candidate