Position Overview
We are seeking a pharmacist intern to support the coordination and execution of various tasks related to Regulatory Affairs at Boehringer Ingelheim and in addition to fulfill the role of Deputy QPPV in Kenya. While prior experience in regulatory affairs and pharmacovigilance would be advantageous, it is not a requirement. A Bachelor of Pharmacy (B.Pharm) qualification and registration with the Kenyan Pharmacy and Poisons Board is required. A willingness to learn and adapt quickly in the Boehringer Ingelheim working environment are essential.
Key Responsibilities:
Dossier life-cycle management: prepare and submit post-registration variation applications in the respective countries in line with Health Authority and Boehringer Ingelheim requirements. Timeous responses to Health Authority deficiency letters.
Preparation of New Drug Application dossiers & Renewal applications: prepare and submit new drug applications and renewal submissions in the respective countries in line with Health Authority and Boehringer Ingelheim requirements. Timeous responses to Health Authority deficiency letters.
Creation of local documents required for submission: drafting of local documents required for regulatory submission to the respective health authorities, e.g., Quality Information Summary (QIS) document, amendment schedules, health authority forms/templates, cover letters, etc.
Support with Regulatory Intelligence monitoring & Reporting: Monthly screening of Health Authority websites for new regulatory intelligence & review of Global Intelligence reports received via Global Regulatory Affairs e.g., Cortellis. Support with the Regulatory Intelligence reporting process.
Artwork/Product Packaging Material reviews: Review/approval of proposed and/or approved product regulatory texts in the BI system.
Regulatory Survey Management: Assist with the completion of regulatory surveys received via the region or Global Regulatory Affairs .
Global Regulatory Affairs Database management: Assist with the timeous update of Global databases, workflow systems, etc. in line with Global RA requirements and timelines.
Adverse event reporting: Assist with the monitoring of the pharmacovigilance inbound communication channels and processing of adverse events.
Pharmacovigilance compliance: Support with implementing activities to enhance PV compliance culture and PV awareness at the local level.
Back-up Qualified Person for Pharmacovigilance: Under technical supervision, in the absence of the local QPPV act as the local PV point of contact for communication and interaction with local regulatory authority in Kenya.
Deputy Local Patient Safety Lead (LPSL) : With the guidance of LPSL, identify and implement internal and regulatory requirements
Qualifications and Skills:
Education: B. Pharm qualification and registration with the Kenyan Pharmacy & Poisons Board. Basic knowledge of regulatory and pharmacovigilance requirements is an added advantage.
Adaptability: Ability to quickly learn and adapt to new tasks, technologies, and working environments.
Communication Skills: Strong verbal and written communication skills to effectively engage with stakeholders.
Organizational Skills: Excellent organizational and time management skills to handle multiple tasks and meet deadlines.
Analytical Thinking: Strong analytical and problem-solving skills to contribute to decision-making processes.
Teamwork: Ability to work collaboratively in a team environment and build positive relationships with colleagues.
Attention to Detail: Meticulous attention to detail to ensure accuracy in project execution and documentation.
Proficiency in MS Office: Working knowledge of Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Time management: Ability to coordinate of tasks and activities so as to maximize effectiveness of individual’s and teams efforts.
Apply via :
jobs.boehringer-ingelheim.com
