TEMITOPE OLANIHUN

Elizabeth, NJ

908-***-**** ad2sd3@r.postjobfree.com

linkedin.com/in/temitope-adeoti-olanihun

Regulatory Affairs and Quality Assurance professional, experience in obtaining and maintaining government approval for drug, medical device and nutritional products, develops strategies to ensure the company’s production activities comply with government regulation SUMMARY OF TECHNICAL SKILLS

High level of understanding of applicable regulations, including FDA (21CFR 312 and 314), ICH (E2A, E2B, E2C), GCP guidelines, EMA regulations, GVP Modules, etc.

Complete knowledge in expedited and periodic reporting timeline requirements set by regulatory agencies worldwide.

Equipped to serves as a liaison between regulatory bodies and operating divisions of the company

Experienced ability to interfacing between R&D, marketing and senior management

Proficiency in writing concise medical narratives and preparing Med Watch and CIOMS forms

Proficiency in using MedDRA and WHO drug dictionary to correctly code adverse event.

Comprehensive knowledge of Oracle Argus safety, Empirical signal and Empirical topics, for case processing, Reporting, Adverse event reporting with keen medical insight for safety and efficacy of products.

Basic knowledge in Pre-and Post-marketing clinical trials, Aggregate reports, IND, NDA, ICSRs, DSURs, PSURs/PBRERs in compliance with Regulatory authorities Computer & Database Skills: Microsoft Office Suite (Word, Excel, Outlook, Access, PowerPoint), Oracle Argus 8.0, Empirical signal, Med DRA, WHODD.

WORK EXPERIENCE

Drug Safety Intern, Sollers – Edison, NJ 2023 - present

Evaluated the source document for completeness and extracted relevant information from the source document.

Processed SUSAR cases from various sources such as clinical trial, post-marketed, literature solicited non- serious and serious adverse event cases

Performed duplicate case search and accurately captured patient, product, and event data in Oracle Argus safety 8.0.

Triaged and coded medical history, laboratory and other investigational test results, adverse event terms using MedDRA 19.1 and WHO drug dictionary

Wrote accurate and detailed clinical case narratives ensuring that all the relevant information is presented in the chronological order of occurrence.

Accurately captured listedness/expectedness of adverse events researching USPI and company core data sheet.

Generated queries using ARGUS interface for clarification, resolving and forwarding to next work flow and communicated to out-side sources to retrieve the required information on the case report.

Consistently used ARGUS features such as action items, contact log and work list for communication and for the follow-up requests.

Performed appropriate case follow-up, generating and requesting follow-up letters.

Responsible for detailed evaluation of the case and forwarding it to Medical reviewer for company’s comment and Reporting.

Participated in contributing towards Aggregate Reports, PSUR/PBRER and PADERs

Empirica signal application training for generating statistical scores for a combination of drug events in a drug safety database and generating signals.

Regulatory Affairs and Quality Assurance Manager, Evans Therapeutics Ltd, Lagos Nigeria. March 2013-August 2022

Providing responses to regulatory agencies regarding product information and issues.

Training staff in regulatory policies and procedures.

Developing, maintaining and safe keeping of standard operating procedures and local working practices.

Maintaining current knowledge of relevant regulations, including proposed and final rules.

Managing activities such as audits, regulatory agency inspections, and product recalls.

Directing the preparation and submission of regulatory agency applications, reports, and correspondence with regulatory agencies as necessary.

Monitoring emerging trends regarding industry regulations to determine potential impacts on Formulating and implementing regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.

Developing regulatory strategies and implementation plans for the preparation and submission of new products.

Investigating product complaints and preparing documentation and submissions to appropriate organizational processes.

Liaising with local and foreign partners and manufacturer on quality, best package and modification suitable for molecules and our temperate region for the company products

Interfacing with government agencies, policy makers and different group and organization on policy binding drug manufacturing, distribution, safety and efficacy thereby giving the best to end users.

Carrying out due diligence and checks on behalf of the company on all products storage, warehousing, logistic from the start to the end and proper record keeping for reference

Participating in high level board meeting and stakeholder rendering professional contribution and advice.

Researching journals, publications and documents to update and broaden product information.

Identifying new strategic opportunity for growth by modifying new and existing drug molecules for better patient compliance and efficacy

EDUCATION

Advanced Drug Safety and Pharmacovigilance Certification, Sollers College, Edison, New Jersey - 2023 Bachelor of Pharmacy, University of Benin, Benin city, Edo state . Nigeria - 2007 WORK AUTHORIZATION

Authorized to work for any US employer without sponsorship.

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