Pharmacovigilance Consultant Resume Example Chubb

PHARMACOVIGILANCE CONSULTANT

Executive Summary

Seasoned pharmacovigilance professional, with over 10 years of industry experience with Major Pharmaceutical corporations

Solid experience in the complete range of Pharmcovigilance processes- ranging from ICSR data entry and analysis /authorship of medical safety documents, to development and implementation of Standard Operating Procedures and Corrective Action Plans.

Core Qualifications

Analysis of aggregate safety data

Safety profile surveillance

Signal detection

Signal/Risk management

Core Data Sheets

SOP Writing and implementation

Authoring PSUR's

Authoring PADER's

Literature searches and analysis

Compliance and metrics

CAPA implementation

Training and development

Professional Experience

Pharmacovigilance Consultant
March 2014 to CurrentChubb － Los Angeles , CA

Worldwide Safety & Regulatory, Quality, Compliance & Analytics Utilize expertise of Pharmacovigilance/Risk Management principals and processes to review and analyze company-wide compliance metrics across therapeutic areas and teams Provide compliance metrics for assigned Pfizer business processes to support continuous process improvement and organizational evolution, driving timely measurable and actionable feedback for proactive change Perform quality review of compliance data Utilize expertise of AE reporting and analysis to develop/enhance the identification and investigation of causal candidates precipitating from root cause Utilize excel for aggregate analysis and reporting of data Generation and quality control check of integrated compliance data relative to areas of delay Assess timeliness of risk management processes in accordance with relevant guidelines and internal standards Author new Work Instruction (WI) for assigned processes to ensure all procedures utilized are documented in accordance with regulations, and internal requirements.

Pharmacovigilance Consultant
August 2013 to January 2015Chubb － Basking Ridge , NJ

Provided medical expertise and input, on assigned safety sections of aggregate safety reports including Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs) Researched, analyzed, and authored summaries of safety trends for assigned Novartis Product Provided written input into various safety documents and submission dossiers, including Core Data Sheet Updates, Internal Expert Statements, and Addendum to Clinical Overview Provided safety summaries for submission dossiers utilizing data from various sources, both internal and external , in close collaboration with Novartis Brand Safety Leader (BSL) Conducted literature searches and reviews to provide written summaries and assessments on relevant publications and studies on various topics of interest for Core Data Sheet updates and aggregate safety reports (PSURs and DSURs) Utilized company specific documents and templates (e.g.
Novstyle) for analysis and reporting of information, and ensure medical accuracy and integrity of data, analysis and conclusions.

Associate Director
February 2012 to July 2013Wakemed － Dunn , NC

Safety Evaluation, Risk Assessment (SERA), Drug Safety &Pharmacovigilance Responsible for managing safety signal detection and post-marketing safety surveillance activities for a large and diverse global portfolio of products in close collaboration with therapeutic category medical safety experts Responsible for recruiting, managing, mentoring, and coaching a Safety Evaluation Risk Assessment (SERA) Team Enhanced established processes for analysis of aggregate post-marketing safety (adverse event) data from Argus for signal detection and safety surveillance purposes Created procedural enhancements for more timely identification, evaluation, and escalation to senior management committees on newly identified safety issues which may warrant further investigation and/or validation Ensured events of interest and /or possible safety signals identified through other NCH processes were adequately managed and consistently monitored, evaluated, escalated, communicated and tracked within established signal detection procedures Ensured appropriate information exchange regarding possible safety issues and close collaboration between SERA team and other core functions including: Medical Safety Experts, PSUR team, RMP authors, and global labeling Created and modified safety surveillance strategies for products based on PSUR commitments, Health Authority requests and/or Risk Management Plan commitments Formulated and implemented safety signal detection scheduling, tracking and management system in response to an MHRA Inspection and resulting CAPAs Coordinated and moderated NCH Quarterly Global Safety Review Committee (GSRC) Meetings in close collaboration with Global Head of Medical Safety and/or EU QPPV Presented detailed safety information identified from review of global aggregate adverse event data for discussion with senior management at GSRC and/or other ad-hoc safety meetings Ensured any actions and/or commitment generated from the Global Safety Review Committee were adhered to and executed in a timely manner, including exchange of information with other Novartis sectors and/or affiliates Participated in and co-lead cross functional team discussions on procedural and technical enhancements to current signal detection process (i.e.
pre-implementation discussions (including review of user requirements) for Empirica) Modified and streamlined existing SOPs, working guidances and associated templates for signal detection and surveillance activities Represented NCH in cross sector implementation planning meetings for EU GVP Module IX (Signal Management) Proposed and initiated implementation of redefined signal detection and management processes for NCH to ensure alignment with EU GVP Module IX Presented the NCH signal detection strategy in audits and inspections, and served as the Subject Matter Expert for the same in work-streams, process improvement initiatives, etc Responded to post- inspection health authority communications and implemented any CAPAs resulting from audits and inspections while ensuring that the process was continually improved Created a cross functional collaborative process with global labeling committee (GLC) to ensure any newly validated safety signals were included in the relevant reference safety information documents in a timely manner Prepared analysis and responses to internal and external requests regarding post-marketing safety data for company products Participated in recall assessments- analyzed adverse event data in Argus, and provided written documentation to senior management on findings for use in senior level Recall Meetings Prepared safety statements for internal/external use Provided trainings to cross functional colleagues on team related processes Provided functional input for due diligence/reverse due diligence activities and license partner agreements.

Associate Director
October 2011 to February 2012FOREST LABS FOREST RESEARCH INSTITUTE － City , STATE

Author submission documents including US Periodic Reports and literature review section of DSUR.
Participate in various task forces created to streamline processes including signal detection, and safety management teams.
Performed data-mining activities for signal detection on various company products.
Provide product safety analysis for ad hoc requests.

NOVARTIS PHARMACEUTICALS
NOVARTIS CONSUMER HEALTH － City , STATE

Medical Services Associate /Manager of Pharmacovigilance Research/Medical Safety Expert
January 2007 to October 2011

Authored US Periodic Reports (PADERs) and performed safety/trend analysis on assigned products for submission to the FDA.
Authored Medical Safety Evaluation sections of Annual Product Reviews Provided post-marketing safety analysis and input for various submission dossiers including: Large scale Rx-to-OTC switch submission for the US FDA, Safety input for CTD modules 2.7.4, 2.5 and 5.3.6.
Provided post-marketing safety input for NDA submissions, IND submissions and briefing books Attended Pre-IND Meeting at the US FDA Provided safety input for Core Data Sheets (Section 4.8 and Section 4.9) Co-authored and/or reviewed PSURs Co-authored local RMP for UK Switch Prepared Health Authority responses and analyzed associated global adverse event data Performed medical safety assessment, evaluation, and review of single and aggregate adverse event case reports Prepared safety statements for internal/external use- Researched/ performed trend analysis for ad-hoc requests regarding potential safety issues arising for assigned products and communicated information as appropriate internally and/or externally.
Served as a team member on various departmental re-engineering task force.

NOVARTIS PHARMACEUTICALS
NA － City , STATE

Drug Safety Scientist /Acting Team Lead
April 2005 to January 2007

Functioned as a "team lead" or primary point of contact for all drug safety case processing issues related to a specific range of Novartis Consumer Health NDA products including: Nicotine Patches, Transderm Scop, and Denavir, along with several other non-NDA products Functioned as a lead resource for training new associates and consultants: Including preparation of convention related training material and execution of training in both a group setting as well as individual mentorship setting.
Served as a team member for a task force created to harmonize conventions between US and affiliate drug safety sites.
Provided training for NCH Adverse Event Data Collection Center (C&PA) where all representatives were trained on the basics of accurate safety information collection.
Served as a primary point of contact for call center nurses for all safety related cases involving NCH NDA products as well as other products assigned.
Performed all Drug Safety Scientist functions as specified below during consultant experience, in addition to the above responsibilities.

NOVARTIS PHARMACEUTICALS
NOVARTIS CONSUMER HEALTH － City , STATE

Drug Safety Scientist - Consultant
October 2003 to April 2005NA － City , STATE

Prepared reports of serious and non-serious adverse events with Novartis Consumer Health products for submission to the Food & Drug Administration.
Composed medical narratives and performed full data entry of adverse events and coding of medical terms within ARGUS database.
Fluently used MEDRA and WHO drug dictionaries.
Reviewed and assessed medical records for reports of adverse experiences with company products.
Reviewed and assessed patient drug safety concerns for Novartis Consumer Health products.
Performed medico-legal review on class action cases.
Served as Quality Control team member to ensure that cases being submitted to the FDA were accurate and complete.
Served as a member of a team created to improve the quality of reports produced by Novartis Consumer and Professional Affairs.
Prepared and presented educational material for discussion in department meetings.
Reviewed medical data to ensure accurate line listing and submissions to the FDA.
Participated in preparation of Annual Product Review and Lack of Efficacy Reports.
Actively contributed to department's development of SOP's and Drug Safety related conventions and assisted in the development of medical and databasing conventions by pointing out problematic topics and issues.
Responded to consumer medical inquiries regarding Novartis Consumer Health products.

Clinical Safety Associate Consultant
June 2003 to October 2003NOVARTIS CONSUMER HEALTH

Processed SAE information per corporate and departmental Standard Operating Procedures (SOPs).
Collected required clinically relevant information for SAE reporting from suppliers.
Actively obtained follow-up SAE information from clinical sites and Clinical Research Organizations (CROs) including responding to queries.
Facilitated the flow of clinical trial information.
Maintained protocol information sheets.
Assisted CROs with SAE reporting process as required.
Administered SAE Reporting.
Entered safety data into Corporate Safety Database and internal tracking system.
Ensured data quality of reports, files, and databases.
Completed all work within acceptable quality standards.
Actively participated in continuous improvement processes.
Contributed to overall therapeutic team performance.
Reviewed Case report Forms (CRF's) to ensure integrity and quality of medical data.

Physician Assistant
November 1999 to August 2003PFIZER, INC Pfizer Pharmaceuticals, Inc － City , STATE

Practiced as a Physician Assistant/ clinical practitioner in the Department of Medicine with Beth Israel Medical Center in which my responsibilities included examining, diagnosing and treating patients.
Interacted extensively with senior management within the hospital to ensue compliance with mandated regulations.
Presented at meetings with other departments.
Created and ran ad-hoc reports for departmental managers.
Maintained clinical databases and updated them with accurate clinical information.

Education

Baruch College － City, State

Master of Business Administration : Finance, 12/02Zicklin School of BusinessFinance

St. John's University － State

B.S : Physician Assistant (PA) Studies, 06/99College of Pharmacy And Allied Health ProfessionsPhysician Assistant (PA) Studies

Skills

streamline, ad, business processes, C, call center, coaching, consultant, continuous improvement, Data Collection, data entry, data-mining, databases, Database, documentation, Documentum, driving, due diligence, senior management, Forms, functional, IND, Instruction, team lead, legal, Lotus Notes, managing, marketing, Meetings, mentoring, MS Excel, excel, exchange, MS Outlook, MS Power Point, Windows XP, MS Word, organizational, process improvement, processes, coding, publications, Quality, Quality Control, recruiting, re-engineering, reporting, Research, Risk Assessment, Risk Management, Safety, scheduling, SOP, strategy, Switch, trend, validation, Author, written

Additional Information

PROFESSIONAL LICENSES AND CERTIFICATIONS Physician Assistant Certification- National Commission on Certification of Physician Assistants New York State Physician Assistant License New Jersey State Physician Assistant License

Resume Overview

School Attended

Baruch College
Zicklin School of Business
St. John's University
College of Pharmacy And Allied Health Professions

Job Titles Held:

Pharmacovigilance Consultant
Associate Director
NOVARTIS PHARMACEUTICALS
Medical Services Associate /Manager of Pharmacovigilance Research/Medical Safety Expert
Drug Safety Scientist /Acting Team Lead
Drug Safety Scientist - Consultant
Clinical Safety Associate Consultant
Physician Assistant

Degrees

Master of Business Administration : Finance , 12/02
B.S : Physician Assistant (PA) Studies , 06/99

Pharmacovigilance Consultant Resume Example

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