Service Representative Customer

**K Reading Road Phone: 908-***-****

Edison, NJ *8817 E-mail: ***********@*****.***

Desmond Okia

QUALIFICATION SUMMARY

Proactive and strategic pharmacovigilance leader with significant pharmaceutical industry experience in areas of Vaccine, Drug/Medical Device Safety, Pharmacovigilance Operations, Compliance, Regulatory Affairs, Quality Risk Management. Expertise in aforementioned areas of more than 10 years, for both clinical trial products and post marketed vaccines, drugs/Medical Devices. In depth knowledge of US FDA, GxP areas including (cGMP, GCLP, and GCP), ICH, GvP, and EU PV regulations to bring a unique perspective and contribute to growth and strengthening of the pharmaceutical sector.

CORE COMPETENCIES:

Global Patient Safety Compliance and Pharmacovigilance experience: In-depth knowledge of US FDA, GvP, GxP areas including (cGMP, GCLP, and GCP), ICH and EU(EMA), UK(MHRA), Japan( PMDA) PV regulations and guidance documents governing both safety reporting and processing for clinical trials and post-marketing environment.

Managing author and review of safety sections of safety documents including PBRER, PADERs, PSUR, SUSARs, DSUR, IBs, ICSRs, IND, NDAs, and Risk Management Plans (RMPs)

4 years of management experience in PV required

8 years of Drug Safety/Pharmacovigilance experience, including both investigational and marketed products

Project Management and People Management

Ability to mentor, coach and guide to help others excel on the job

Preparing and responding to Regulatory Agency Inspections as well as internal and external audits

End to end Case Processing (Receipt, Triage, Data Entry, Assessment, Quality Review, Query Generation, Manufacturer Notification, and coding)

Extensive knowledge of Adverse Event and drug coding conventions (MedDRA, WHO-DD)

Knowledge of end user experience/configuration of safety databases (ARGUS safety system database)

Opening and Investigating Quality Events, Deviations and CAPA

Proficient computer skills including Microsoft Word, Microsoft PowerPoint, and Microsoft Excel

EMPLOYMENT HISTORY

Pfizer Inc, Peapack, NJ, USA April 2021 – April 2023

Manager, Worldwide Safety and Regulatory Quality Control (Contract)

Oversighted global Individual Case Safety Report (ICSR) collection, processing, and reporting in accordance with regulatory authority reporting requirements and Pfizer’s Standard Operating Procedures (SOPs)

Oversighted workload distribution in coordination with Drug Safety Team Lead and Country Safety Leads

Collaborated with cross functional teams ( Case Processing, Quality/Compliance and Safety Systems management) to ensure efficient and compliant case processing

Led the aggregation, trending, and analysis of case processing metrics, plus facilitated the discussion of metrics, trends, root causes of late submissions of case processing to identify areas for process improvement

Participated in the development/update of Standard Operating Procedures (SOPs), and Working Instructions (Wis), processes and practices for safety data handling in accordance with drug safety and pharmacovigilance regulations, ICH standards, guidelines, and industry best practices to ensure timely and compliant submissions to worldwide regulatory agencies

Oversighted Pharmacovigilance(PV) vendor case management (submission timelines, quality deliverables, and compliance to regulations).

Oversighted safety information processing, reconciliation, and reporting by outsourced vendors including review of ICSR and reviewed case processing metrics

Developed and mentored resources regarding case processing, reporting and distribution of ICSR globally

Developed Key Performance Indicators (KPIs) dashboards, reports, and tools to track timeliness/ regulatory compliance of deliverables regarding case processing

Collaborated with cross-functional teams to resolve late ICSR submissions by ensuring the development and implementation of strategies for case management process, Root Cause Analysis(RCA), Quality Event Investigation, and Corrective and Prevention Action (CAPA) and Deviation management implementation

Prepared and responded to Regulatory Agency Inspections as well as internal and external audits

Monitored industry best practices, and changes in global safety regulations and guidelines for marketed and investigational products, and recommended changes and upgrades to existing department policies, and SOPs

Developed, reviewed, and updated drug safety forms and templates, and harmonized with relevant clinical operations forms and templates (SAE data collection form, PADER template etc)

Provided input on quality services and policies collaborating with Directors and Senior Directors

Evaluated case management processes and procedures against outcomes to identify methods to improve efficiency, accuracy, and compliance with Pfizer and regulatory requirements. Encouraged continuous improvement

Bayer U.S. LLC, Whippany, NJ, USA October 2020 – March 2021

Senior Manager of Medical Device Safety, Pharmacovigilance (Contract)

Conducted global Pharmacovigilance (PV) business processes and analyses/trends safety data sets related to product quality complaint handling, regulatory reporting and clinical development for Bayer medical devices and combination products worldwide.

Provided counsel as Pharmacovigilance medical device subject matter expert to ensure that an effective vigilance, post-marketing surveillance (PMS) and trending systems are implemented and maintained in compliance with global requirements/laws. Worked cross-functionally to generate solutions and implement process standards consistent with device industry best practices and global regulations

Provided content input to Project teams for designing, planning, and conducting analyses of safety data for the assessment of medical device safety and performance

Provided review and input to device risk management documents, including hazard analysis, user risk assessments, human factors protocol, etc.

Was responsible for the production and accuracy of medical device analysis, interpretation of results and content contributions to PMS and Vigilance activities

Assisted in preparing and responding to Regulatory Agency Inspections as well as internal and external audits

Independently reviewed vigilance data sets and prepared reports for submission to the Health Authorities under strict timelines and resolved respective queries regarding product safety

Covance Clinical Development Services (LabCorp), Princeton, NJ, USA August 2018 – April 2020

Drug Safety Associate (Contract)

Triaged and assigned priority to incoming ICSR events and classified them according to regulatory reporting criteria.

Evaluated cases for seriousness, relatedness, and expectedness according to the protocol, investigator brochure, and /or package insert.

Provided review and input to device risk management documents, including hazard analysis, user risk assessments, human factors protocol, etc.

Utilized Veeva Quality Vault, Microsoft Office 365, MS SharePoint, MS Project, Excel one Note, Smartsheet ARGUS software and MedDRA coding to process Adverse Events and Serious Adverse Event reports.

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

Utilized MedDRA dictionary for coding clinical events and WHODRUG dictionary for coding medications.

Prepared narratives, according to prepared template; processed cases from clinical trials and post-marketing products

Supported the submission and distribution of reports and relevant tracking of distribution of Follow-Up letters

Conducted follow-ups to ascertain further information and or to obtain product samples for Adverse Event reports

MERCK Research Laboratories, Rahway, NJ, USA August 2016 –August 2017

Senior Manager Clinical Safety and Regulatory Analyst III (Contract)

Authored safety sections of Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), SUSARs, PADERs, CCDS(CCSI), RSI, IBs, CSRs, NDAs, Addendum Reports and US Periodic Safety Reports (PSRs)

Used ARGUS safety database, including implementation, migration, and reporting

Facilitated the development and management of Pharmacovigilance System Master File (PSMF)

Reviewed technical documents (both self-review and peer review) for data accuracy, consistency, correct use of grammar and consistency with the MERCK and regulatory authority guidelines

Managed safety signals for drug products, both those in development and marketed products, for the collection and identification of safety signals using data for signal surveillance activities, categorization, and prioritization of safety signals

Vendor management oversight, and readying organization for Inspection Preparedness

Assisted in preparing and responding to Regulatory Agency Inspections as well as internal and external audits

Identified quality issues and recommended/approved changes, CAPA for manufacturing and compliance to ensure adherence to regulatory requirements

Participated in aggregate activities involving exchange of adverse experience data with licensing partners involved with MERCK as part of clinical trial investigations, Pharmacovigilance Agreements(PVA), supply agreements, comarketing agreements divestitures and co-promotional agreements

Supported early and late phase development/drug development

Collected, compiled, and monitored compliance and quality metrics

Bristol- Myers Squibb, Pennington, NJ, USA January 2016 - April 2016

Senior Drug Safety Reviewer (Contract)

Triaged and evaluated Individual Case Safety Reports (ICSRs) for report type, seriousness, causality, expectedness/labeling, and reporting

Evaluated cases for seriousness, relatedness, and expectedness according to protocol, investigator brochure and/or package insert

Entered case information and utilized ARGUS safety database, including configuration, implementation, migration, and reporting

plus, MedDRA dictionary for coding clinical events and WHODRUG dictionary for coding medications

Wrote narratives summaries on assigned ICSRs, according to prepared template; processed approximately 20 cases per day from clinical trials and post-marketing products

Re-assessed pregnancy cases and off -label use of ICSRs for a Corrective and Prevention Action (CAPA) from a European Medicines Agency (EMA) audit

Attached appropriate queries for missing/discrepant information and added follow-up letters as per Standard Operating Procedures

Monitored workflow status of adverse events reports in the safety database to ensure compliance with case processing timelines

Johnson & Johnson, Horsham, PA, USA April 2015 –July 2015

Drug Safety Associate (Contract)

Triaged and evaluated Individual Case Safety Reports (ICSRs) for report type, seriousness, causality, expectedness/labeling, and reporting

Processed cases with accuracy and consistency at the various stages of the workflow system using ARGUS

Evaluated processes and procedures against outcomes to identify methods to improve efficiency, accuracy, and compliance

Performed necessary follow-up for missing, discrepant, or additional information from source documentation

Prepared clinical narrative summaries for Adverse Events reports independently from clinical studies and spontaneous post-marketing reports

Developed and maintained expertise knowledge for applicable corporate and global regulations, Standing Operating Procedures, Working Instructions, MedDRA coding dictionary and MedDRA points for data entry conventions and for such functions in the safety database

Collaborated with key stakeholders for example Regulatory Authorities, Contract Research Organizations, Local Safety Officers and Marketing partners regarding Drug Safety data collection and data reconciliation

Monitored workflow status of Adverse Event reports in the safety database to ensure compliance with regulatory authority processing timeline guidelines

AstraZeneca, New Jersey, USA April 2013 –March 2015

Drug Safety Associate (Contract)

Triaged and assigned priority to incoming events and classified them according to regulatory reporting criteria. Evaluated cases for seriousness, relatedness, and expectedness according to the protocol, investigator brochure, and /or package insert.

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

Utilized MedDRA dictionary for coding clinical events and WHODRUG dictionary for coding medications.

Prepared and reviewed narratives, according to prepared template; processed cases from clinical trials and post-marketing products

Greenwich Clinical Commissioning Group a CRO, London, UK May 2007 – September 2012

Drug Safety and Pharmacovigilance Specialist (Full time)

Reviewed Adverse Event (AE) and Serious Adverse Event (SAE) reports from development and/or post marketing sources to assure data accuracy, validated ICSRs assessments as per regulatory authority requirements

Utilized Oracle ARGUS software and MedDRA coding to process AE and SAE reports

Authored and reviewed safety sections of Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), IBs, CCDS(CCSI), RSI, CSRs, NDAs, Addendum Reports and Periodic Safety Reports (PSRs)

Provided oversight of Pharmacovigilance activities including vendor management, and ongoing process

EDUCATION

Bachelor of Pharmacy Degree, Jamia Hamdard University, New Delhi, INDIA.

July 2005

Master of Science (Public Health), London School of Hygiene and Tropical Medicine, University of London

Ongoing Online- expected completion date 2025

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