Brenda Janolan

* ****** **** ****. *********** NJ 08067

Mobile: (610) 635 – 6465

Email: ad1syb@r.postjobfree.com

Profile

I am a Pharmacovigilance Professional with a Bachelor of Science Degree in Nursing from Thomas Jefferson University. Clinical therapeutic experience in Medical surgical, Telemetry, Oncology, Psychiatry, L&D, and Peds (1998 – 2001). Pharmaceutical experience includes 17 years in the following areas of expertise: Drug Information, Drug Safety, and Medical Device. Advance knowledge in FDA,

EMA and PMDA regulatory compliance. Well versed in 21 CFR Part 803. Proficient in global GMP and Regulatory requirements. Working knowledge in CAPAs, INDs, recalls, QA, JDE, Literature, legal

(litigations), clinical trials (drugs: phases I to IV – medical device: class 1-3 – transplantable devices, mesh, minimally invasive products).

Accomplishments

Contributed and participated in internal and external audits. Contributed towards amendments of SOPs and work instructions. Functioned at a subject matter expert (SME) level for special projects; particularly as issues are identified. Assisted in developing and implementing new procedures or systems. Proven track record of completing projects within defined timelines. Received recognition and awards for a variety of accomplishments which involved promoting team building, completion of special projects, and recognition by management and peers for being an exceptional team player. Experienced member of a team who have proactively assisted to resolve 483s and other audit observations.

Technical Skills

Trackwise, Salesforce, MS Office Suites, Argus, Aris G, SKYPE for business, SharePoint, Docusphere, SAP, JD Edwards, Sceptre, EtQ, Unity, ONE MD, S3 (Safety Surveillance Systems), Cognos, Webbi, CATs Web, Concur, Windchill, Metalogix, Google, ONE NOTE, Outlook Experience:

November 2022 – May 2023

(Clinician) Medical Device Reporting Level 3, ALKU (OLYMPUS – Consultant)

Analyzed complaint records for pertinent information regarding medical device complaint reporting to FDA

Expert handling with Trackwise

Perform independent follow-ups and due diligence for proper medical device reporting documentation

Performed MDR submissions

Collaborated with team members for assessment of sentinel events, not currently on reportability matrix

Performed literature search (online / social media) and reviewed for Medical Device related issues July 2020 – June 2022

Complaint Specialist II (Clinician), RQM PLUS (PFIZER – CONSULTANT)

Review complaints and develop rationale on reported severity and documented severity in the risk file

Review product quality complaints and adverse events, evaluate investigation requirements, and close with rationale or indicate additional activities

Review any non-reportable decisions (non-serious complaints) to ensure appropriate rationale and conclusion. All determinations documented in complaints database, linked to Argus complaint number, and closed

Coordinate/investigate device complaint in accordance with 21 CFR Part 820.198 and direct events to the appropriate investigation site (manufacturing site, distribution, design center, safety, and regulatory)

Review and evaluate complaints for MDR decisions in accordance with 21 CFR Part 803

Interface with site engineers / manufacturing/ triage to complete device investigations

Support revision and compliance to complaint handling policies and procedures May 2019 – May 2020

Postmarket Surveillance Consultant, E. G. LIFE SCIENCES (PHILIPS – CONSULTANT)

Support post market surveillance activities and other quality tasks

Applies professional expertise and adhere to company policies and procedures to resolve a variety of issues

Remediated 6000 records for reportability and coding issues

Filed Service Reports as needed

Other tasks as needed

March 2014 – November 2018

Customer Quality Specialist III, DEPUY SYTHES

Supported Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. Additionally, these activities may have included Non-Conformance Investigations, Field Actions, Documentation Management and Metrics

Responsible for the oversight and direct support of technical evaluations, and investigational tasks required for complaint processing/closure

Worked alongside Quality Engineers, Manufacturing, Product Development, and other functional experts as needed to ensure clear understanding/investigation of applicable issues

Interfaced with Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events

Prepared for and attended MDR team meetings on behalf of the Complaint Handling Unit

Reported Initial and Supplemental MDR’s

Provided guidance and direction to peers as well as be involved in the field action and complaint handling process

Prepared weekly and quarterly complaint handling reports

Responsible for processing and closing complaints in a timely manner

Maintained current knowledge of the FDA regulations (frequent reading of the trade press/emails, FDA news bulletins, attending job-related webinars, or outside courses when appropriate); consider innovative solutions to meet changing regulatory compliance goals.

Required to know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance at all times

Participated in company compliance program-related activities as denoted by supervisor or Chief Compliance Officer

April 2013 – March 2014

Drug Safety Associate, RESEARCH PHARMACEUTICAL SERVICES (RPS)

Initial assessment (triage) and case level review of all serious adverse event (SAEs) and spontaneous reports received in compliance with SOPs and regulatory requirements

Data entry, case processing and coding in Medra of SAEs and adverse events (AEs) for post marketed products and investigational compounds

Maintain accuracy, consistency, and completeness of safety database and/or tracking log

Assists in the review of legacy data for completeness and consistency as entered in the safety database

Submits or assists with submissions of required reports/documents to Agencies, IRBs, ECS and Investigators on safety issues as required

Assist in authoring position statement on key safety issues

Assist with the AE-SAE reconciliation process

Draft safety management plan

Interact with the investigational sites and internal clinical teams to provide safety expertise

Generate queries for the collection of additional information for AEs and SAEs

Assist with the generation and review of regulator and ad hoc reports

Assist with the development of data entry conventions to ensure across database users and products

Communicate via phone/fax/e-mail with physicians, study coordinators, consumers, caregivers, and other parties reporting adverse events to obtain all relevant safety information

AUGUST 2012 – APRIL 2013

ADVERSE EVENT COORDINATOR III, JOULE, INC. (MERCK – CONSULTANT)

Determined on the basis of standard operating procedures and U.S. FDA regulations, the prompt periodic classifications of each adverse experience contained in the report received for marketed and investigational products

Reviewed and processed according to the SOPs all adverse event information received for domestic and non-domestic sources which involved the sponsor’s products July 2011 – June 2012

SAFETY SURVEILLANCE ASSOCIATE, PFIZER

Provide support for the review of potential adverse events of pharmaceutical products

Review and assess domestic/international clinical trials and post-marketing surveillance AE reports on marketed products

Determine regulatory reporting requirements based on assessments of seriousness and labeling of selected adverse events terms

June 2010 – June 2011

Drug Safety Associate, SMITH-HANLEY (PFIZER – CONSULTANT)

Conduct clinical assessment and process information on reported adverse drug experiences including accurate data entry in safety database

Collect and organize information from all sources that includes coordinating and tracking the processing of cases through the safety database

Document classification of reports according to the following criteria: source, serious, and non-serious data entry priority, initial vs. follow-up report

Check reports for completeness, accuracy, and consistency of information and check for duplicate cases

Develop and utilize knowledge in the performance of triage or reports of potential adverse events

Classify, track and document potential adverse events which do not meet criteria for entry into AEM system

Determine requirements for flagging cases for further follow-up including query resolution and actions by Country offices

Select every term using clinical judgment and assess expectedness/listedness based on the plural Company reference documents

Determine regulatory reporting requirements based on assessment of seriousness, causality, and expectedness in accordance with regulatory guidelines and product labeling

Understand applicable corporate and global regulations, SOPs and writing practices

Understand data entry conventions and expertise of search functions in Safety database FEBRUARY 2010 – MAY 2010

Drug Safety Associate, YOH SCIENTIFICS (JANSSEN – CONTRACTOR)

Assume primary responsibility to collect details of adverse events received by phone or mail for ethical and biologics and perform initial assessment according to the local procedures and in accordance with company global drug safety procedures

Create initial reports by directly entering information into Drug Safety database, amend reports and enter follow-up information as acquired, and prepare report for FDA submission

Maintain continuous knowledge expertise in local and global requirements for safety reporting

Responsible in assuring proper reporting of adverse events within the timelines mandated by Global Drug Safety

Collect, and/ or organize the data collected as part of Pharmacovigilance plan, RMP, product recalls and surveillance activities

Ability to interpret, analyze and clearly present scientific and technical data in verbal and written. Functional knowledge of EXCEL, PowerPoint, Microsoft Word. Team player, ability to work under tight timelines and poise. Ability to thrive in a global, matrix environment. Ability to manage high workload and critical issues Education

MAY 1998

BACHELOR OF SCIENCE IN NURSING, THOMAS JEFFERSON UNIVERSITY JUNE 1992

HIGH SCHOOL, PHILADELPHIA HIGH SCHOOL FOR GIRLS

4.0+ GPA / Suma Cum Laude

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