Summary
Overview
Work History
Education
Skills
Industrial Attachment
Industrial Attachment Details
Leadership Positions Held
Education Background
Personal Information
References
Certification
Timeline
Generic

BARONGO MACKONGE KIMWEI

PHARMACIST

Summary

  • To work in a challenging pharmacy related position in an organization that will provide the necessary practical training and opportunities for career and self-development.
  • To pursue a highly rewarding career in a challenging work environment and utilize my skills and knowledge towards the realization of the organization’s mission and vision.
  • Proficiency in regulatory affairs
  • Proficiency in Drug safety and Pharmacovigilance
  • Health product registration and retention.
  • Prescription interpretation and patient counselling.
  • Diligent Regulatory Affairs pharmacist with 6 years of supporting compliance management experience,developing effective processes & executing regulatory affairs initiatives for the pharma industry . Works well with consulting cross-functional teams on minimizing regulatory risk. Goes above and beyond to manage priorities and problem-solve with quick turn-around expectation.

Overview

7
7
years of professional experience
3
3
Certifications

Work History

EAST & SOUTH AFRICA REGION REGULATORY COORDINATOR

MSN Laboratories Pvt.Ltd
08.2023 - Current
  • Supported successful product launches by meticulously preparing submission dossiers and securing timely approvals from authorities.
  • Managed complex regulatory projects, consistently meeting critical deadlines and budget constraints.
  • Assisted in developing labeling content compliant with regional requirements, ensuring accuracy and consistency across multiple markets.
  • Reviewed marketing materials for accuracy and compliance with applicable regulations, minimizing legal exposure for the company.
  • Established strong relationships with key stakeholders at regulatory agencies, fostering open communication channels for prompt issue resolution.
  • Coordinated recall or market withdrawal activities as necessary.
  • Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
  • Maintaining contacts and sharing relevant information with relevant disciplines, internally and externally, nationally, and internationally
  • Report ADRs and other pharmacovigilance reporting tools from principals to the regulatory bodies PPB
  • Import permit application and follow up for approval

Pharmacovigilance Associate

HARLEYS LIMITED
08.2021 - 08.2023
  • Responsible for coordinating and performing adverse event triage, data entry into adverse event database, and review of the entered cases for quality, Preparing, reviewing, and implementing company SOP for Pharmacovigilance activities in the country, Submitting the following to the regulatory body: Adverse Events, Periodic Safety Update Reports and Periodic Benefit-Risk Evaluation Reports (PSUR/PBR), Company-sponsored pre-and post-registration study reports, Risk Management Plans (RMPs), Ensuring that all personnel involved in pharmacovigilance activities should be aware of the principles of pharmacovigilance that affect them, and all personnel shall receive relevant training, Have an oversight of the PMS activities of the MAHs products registered in the country, Ensuring that training is provided before implementation of new or revised procedures
  • Records of training should be maintained.
  • Played an instrumental role in successful audits by maintaining organized files and providing detailed explanations regarding pharmacovigilance activities when necessary.
  • Reduced workload backlog by effectively prioritizing high-priority cases based on severity level and regulatory deadlines during peak periods of volume influx.
  • Assessed and distributed pharmaceutical product adverse event documents.
  • Conducted case reconciliation with internal departments, distributors, affiliates and business partners.
  • Oversaw adverse events case reporting and conducted follow-up.

REGULATORY AFFAIRS & PHARMACIST IN CHARGE

UNISEL (K) LIMITED
10.2018 - 08.2023
  • Duties and Responsibilities: Compliance and Regulatory, New MOH registration applications, submissions and follow-ups, Product Analysis applications, submissions and follow-ups, Product variations submissions, notifications including follow-ups, Checking Packaging/Shelf Life/Storage Package Insert claims on Goods Received in warehouse complies with registration dossier/ variations as submitted, Timely PPB Annual Product Retentions, Communication with suppliers regarding updates, submissions and approvals, Reporting ADR’s + PV Pharmaco-vigilance or suspected parallel importation, Timely PPB Annual Product Retentions, Pharmaceutical Reps Permits, Company licenses (premise, wholesale, pharmacist), Maintaining Personal Annual PSK Membership/CPD’s and PPB Practice Licence, Self-inspections and follow-ups weekly, Schedule training of inward and outward warehouse staff is regularly conducted, Prepare training material for trainings, Carry out product checks and handle product non-conformities, Approval of customer returned stock for resale, Facilitate and assist with telephonic query resolution for all calls of a pharmaceutical nature regarding ethical lines or other, Providing excellent customer service while running a smooth and efficient operation, Ensure batch tracking is implemented on all stock that requires such control.
  • Designed and implemented continuing education programs for staff members, keeping them up-to-date on industry trends, new medications, and best practices in pharmaceutical care.
  • Served as the primary point of contact for regulatory audits and inspections, demonstrating the pharmacy''s commitment to operational excellence.

MINISTRY OF HEALTH INTERNSHIP

01.2017 - 10.2018

Unisel pharma

01.2017 - 10.2018
  • Duties & Responsibilities: Compounding, Prescription interpretation and Dispensing, Ensure compliance of pharmaceutical practices according to national regulations, Ensure the quality of all medical supplies (medicines, medical devices, and laboratory equipment), Ensure management of medicines and medical equipment: order, storage and distribution, Analyze the consumption data, in accordance with medical protocols, Ensure good practice of drug delivery, Supervise staff in charge of the daily management of products, Supporting the development of strategies, Actively participated in developing of plan and annual budgets, Participate in monthly reports in accordance with directives.

Education

Bachelor of Science - Pharmacy

JOMO KENYATTA UNIVERSITY OF AGRICULTURE & TECHNOLO
04.2001 -

Skills

Regulatory Submissions

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Industrial Attachment

SEP-DEC 2015

Industrial Attachment Details

  • Mama Lucy Level V Hospital
  • Ellys Pharmaceutical Company
  • Haripharm Pharmaceuticals

Leadership Positions Held

  • Class representative at JKUAT
  • Welfare representative JKUAT pharmacy students’ organization

Education Background

  • Competency certificate in Safety and Pharmacovigilance
  • Stage two pharmacy and poisons board
  • Bachelor Of Pharmacy, Jomo Kenyatta University Of Technology And Agriculture
  • Kenya Certificate of Secondary Education, Kanga Boys High School- A plain

Personal Information

  • Date of Birth: 03/27/1992
  • Gender: Male
  • Marital Status: Single

References

  • OSCAR MUTISO, UNISEL PHARMA (K) LTD, 0721675709
  • DR FREDRICK OKARI, HOMABAY COUNTY REFFERAL HOSPITAL, 0720959315
  • DR PRITESH PANCHOLI, NILSON PHARMACEUTICAL COMPANY, 0722582513

Certification

Certi

Timeline

EAST & SOUTH AFRICA REGION REGULATORY COORDINATOR

MSN Laboratories Pvt.Ltd
08.2023 - Current

Pharmacovigilance Associate

HARLEYS LIMITED
08.2021 - 08.2023

REGULATORY AFFAIRS & PHARMACIST IN CHARGE

UNISEL (K) LIMITED
10.2018 - 08.2023

MINISTRY OF HEALTH INTERNSHIP

01.2017 - 10.2018

Unisel pharma

01.2017 - 10.2018

Bachelor of Science - Pharmacy

JOMO KENYATTA UNIVERSITY OF AGRICULTURE & TECHNOLO
04.2001 -

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