Safety Manager

Raymond Feeks Jr.

** ******* ***** • Oxford • NJ 07863

Cellular 973-***-**** • Home 908-***-****

j4n0xe@r.postjobfree.com

SUMMARY

A highly dedicated professional offering an extensive background and increasing responsibility to initiate, coordinate, and complete projects in

a time and cost-effective manner. Organized and dependable, adept at implementing, multi-faceted operational procedures while working

alone or as an integral part of a team. Exhibits solid people skills with a balance of tact and tenacity when interfacing with individuals on all

levels. Possesses strong communication skills. Able to visualize and communicate big picture goals and provide the means to attain them.

Sound professional attitudes, strong work ethic, and pride in personal performance.

EXPERIENCE

Celgene Corporation • Summit, N.J • Jan2010 to Feb2012

Drug Safety Specialist

• Ensure that individual Adverse Event Case Reports are evaluated, investigated and accurately computerized

• Execute QC on key fields of serious and non-serious cases and update fields in ARISg based on QC, as needed

• Execute case assessment( review events, determine labeledness, identify co-manifestations, review coding, determine causality)

• Create narrative

• Create major modifications following Medical Review

• Create follow-up letters

• Execute receipt of Drug Safety phone calls and complete telephone AE form

• Create phone call communication logs in ARISg

• Support the triage of cases and assessment of complex cases conducted by Senior Specialist as needed

• Create draft company comments for serious cases

• Contribute to the orientation and training of staff as needed

MannKind Corporation. • Paramus, N.J. • Jun2008 to Dec2009

Senior Drug Safety Associate

• Participate in the triage process of incoming adverse event cases to ensure timely and effective assessment and evaluation of cases

• Track and log serious adverse events (SAE’s) received from Investigator Sites or Contract Research Organizations

• Ensure that expedited reports are processed and sent to the Regulatory Affairs Department within established timelines

• Assist in the drafting of letters to investigators regarding 7 day and 15 day IND safety reports

• Assist in the distribution of safety reports to investigators

• Assist in the drafting of the analysis of similar events and generate “similar events” search and “previously submitted” line listings

• Review SAE’s received from investigator sites/CRO’s to ensure completeness and accuracy of the SAE information. Communicate directly to investigator sites and CROs’ to reconcile inconsistencies

• Query the investigator site/CRO for clarifications and/or missing data as follow up SAE information

• Reconcile SAE’s contained in the Clinical Trials Database and the Safety Database

• Resolve database discrepancies and end of study reconciliation

• Write and review draft SAE narrative

• Code adverse events and medical history using the MedDRA dictionary and drugs using the WHO-DRL dictionary when applicable

• Participate in project/protocol meetings and in meetings with CRO’s

• Mentor junior level Drug Safety Associates and train others regarding SOP’s, policies and procedures as required

• Assist in the writing or review of study protocols, informed consents, study reports, investigator brochures, and other safety reports, i.e. annual report to the IND, ISS and assist in safety-related training for clinical operations

• Assist with the preparation of ad hoc reports, including but not limited to the following:

Line Listings (CIOMS II and customized Line Listings)

Reconciliation Reports

Outputs for routine company deliverables (e.g., IB, ASR, DSMB

Outputs, SOC analysis 15 day IND letters, Annual IND)

• Present study materials at Investigator/study launch meetings when required

• Review monitoring plans

• Participate in the development of protocols and Case Report Forms

• Participate in writing clinical trial reports

• Participate in company-required training programs

.

Genta Inc. • Berkeley Heights, N.J. • 2003 to 2008

Manager Drug Safety and Surveillance/Medical Affairs

• Review SAE Clinical Trial Reports from CRO's, Investigator’s, and post-marketed reports.

• Perform review, assessment and data entry of clinical trial and post-marketed reports into safety database (ARGUS), which includes writing

of narrative summary, coding of adverse events and medical history utilizing MedDRA, coding of concomitant medications using the WHO

Drug Dictionary, and query generation.

• Coordinate the regulatory and medical review of incoming SAE reports (Individual Case Reviews: review and approval of all potential expedited

reports), working with Regulatory Affairs to determine reporting timelines, and assist with the submission of safety reports to the FDA.

• Work with Regulatory Affairs to determine reporting timelines, and assist with the submission of safety reports to the FDA. (IND, ISS, NDA

Periodic Report, 15-Day Alert Reports).

• Perform aggregate safety data review (clinical review of all adverse event reports, review of literature reports, detection and evaluation of

potential safety signals).

• Participate in oversight of ongoing clinical trials and in the preparation of an NDA.

• Assist in the development, implementation and maintenance of policies and standard operating procedures for processing and monitoring

investigational product safety and post-marketing information.

• Assist in the development, implementation and training of the drug safety database (ARGUS) in processing and monitoring of investigational

product safety and post-marketing information.

• Interaction with Clinical Teams, Quality Assurance, Regulatory Affairs and Marketing regarding all safety issues.

• Perform coding review of adverse events, medical history and concomitant medications for new and ongoing clinical trials in collaboration

with Project and Data Manager's.

• Ensure collaboration with Pharmacovigilance colleagues in Affiliates and Entry Sites (CRO's, Partners, etc.).

• Responsible for safety presentation and training at Investigator Meeting's.

• Assist in coordinating the activities of study managers to ensure compliance with corporate standards in receipt and handling of safety information

(Presenting and training at Investigator’s Meeting’s.

• Identify and discuss safety issues internally and make recommendations for appropriate action.

• Assist in providing pharmacovigilance input to clinical development plan and relevant documents (e.g. protocols, investigator brochure,

integrated safety summaries, and other documents needed for product approval).

Pfizer, Inc. • Morris Plains/Bridgewater, N.J. • 2001 to 2003

Regulatory Safety Associate Worldwide Safety

• Review reports of adverse events on Pfizer marketed products obtained from the following sources: Clinical trials conducted by PPG, and PGRD;

US and International spontaneous reports forwarded by consumes, healthcare professionals, Pfizer country offices, the field force, Pfizer Call

Center, and other suppliers; literature reports; legal reports.

• Assess reports of adverse events and determine reportability in accordance with FDA and ICH guidelines.

• Select event terms using clinical judgment and label selected event terms against the appropriate US and International product labels in the

corporate labeling database.

• Determine regulatory reporting requirements based on assessment of seriousness and labeling of reported adverse event terms.

• Coordinate and track the processing of adverse event reports through the Corporate Safety Database (ARISg) and RSGT (Regulatory Safety

Group Tracking) Databases.

• Process expedited MedWatch and CIOMS 1 adverse event reports.

• Take ownership for the processing of individual 15-Day alert reports within regulatory timelines.

• Assist with Pfizer campaign reports (ICT) by performing initial review and triage to determine if the case meets criteria for entry into the

Corporate safety database.

• Interact with members of Worldwide Safety, Safety Evaluation and Epidemiology, PPG, PGRD, and other suppliers concerning safety related issues.

• Participate in a multi-functional therapeutic product team within Worldwide Safety and serve on departmental task forces as necessary.

• Code adverse events and medical history utilizing MedDRA, and code concomitant medications utilizing the WHO Drug Dictionary.

• Review discrepant data for Periodic reports prior to FDA submission.

• Maintain current knowledge of aligned products within a therapeutic area.

• Maintain knowledge of all applicable FDA and ICH regulations and guidelines.

Pfizer, Inc. • New York City • 1999 to 2001

Manager Serious Adverse Event Resource Group

• Co-managed ARTFORCE Closeout Initiative to optimize procedures and standards for reconciliation between PPG Worldwide Clinical Project

Database and Corporate Safety Database (AEM) through the Serious Adverse Event Resource Group.

• Played a key role in the development of the ClinSafe database program, which included training and mentoring.

• Assist with interview process of consultant group for the Closeout Initiative, as well as training, supervision and mentoring.

• Responsible for quality control of each document that is presented to Worldwide Safety, Clinical Data Operations and Project Teams.

Pfizer, Inc. • New York City • 1995 to 1999

Serious Adverse Event Coordinator/Team Leader

• SAE Resource Group Team Leader and Member of Disease Management Team (DMT's) for Cardiovascular and CNS products, while also

providing cross coverage of all Pfizer products.

• Facilitate Clinical Trial SAE reporting to Worldwide Safety by writing initial SAE reports and obtaining follow-up information, answering SAE

Hotline, perform safety review of ALL case report forms (CRF's), generate SAE related data clarification forms (DCF''s) following CRF review.

• Provide reconciliation for Annual Progress Reports and database releases.

• QC AEM reports from CRO's and CRA's.

• Perform direct data entry of SAE reports into the Corporate Adverse Event Monitoring (AEM) database.

• Enhance prospective reporting to the Disease Management Teams (DMT''s) personnel regarding Clinical Site and Contract Research

Organization (CRO) performance.

• Participate in planning of new protocols and proactively identify safety issues during protocol development.

• Travel to study sites to provide support and participate in safety related training programs for Investigator's and Clinical Study Coordinators.

• Responsible for safety presentation at Investigator Meeting's.

Sandoz Pharmaceuticals • East Hanover, N.J. • 1990 to 1995

Clinical Safety Specialist

• Responsible for classification and submission of Spontaneous and Clinical Trial Reports as well as Periodic Reports in accordance with FDA

regulations.

• Prepare NDA Periodic Safety Reports for all Sandoz prescription and OTC products.

• Assure quality on all work for completeness and accuracy.

• Member of Sandoz Drug Safety Medical Review Committee regarding ADE profiles of Sandoz marketed drug products.

• Interaction with staff from Medical Affairs, Regulatory Affairs and other therapeutic areas to discuss ADE safety data.

• Interaction with healthcare professionals and consumers to obtain complete ADE information (follow-up queries).

• Direct data entry of reports into SAVES (Sandoz Adverse Event Monitoring System).

Caremark Homecare • Totowa, N.J. • 1986 to 1990

Pharmacy Lab Supervisor

• Process and prepare intravenous medication orders specializing in cancer chemotherapy, pain management, antibiotics and IV

nutrition.

• Monitor patient drug therapy to ensure clinical appropriateness.

• Investigate and document possible adverse drug reactions.

• Maintain Clozaril records through clinical monitoring of patient's WBC count, and prepare reports for Clozaril Registry.

• Maintain inventory of medications and supplies for pharmacy.

• Supervised supportive personnel.

EDUCATION

St. John's University • Jamaica, New York

B.S Pharmacy

COMPUTER KNOWLEDGE

• ARGUS, ARISg, Clintrace, MS-Word, MS-Excel, MS-PowerPoint, AEM (Adverse Event Monitoring System), ClinSafe (Patient

Tracking System), RSGT (Regulatory Safety Group Tracking)

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