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Tammy Karikari

Senior medical device specialist software and artificial intelligence assisted medical devices

MHRA

Technologies

My Portfolio Highlights

My New Project

Introduction to DataCamp Projects

My New Course

Introduction to Python

Data adventurer, fearlessly exploring the depths of complex datasets.

My Work

Take a look at my latest work.

course

Introduction to ChatGPT

course

Understanding Artificial Intelligence

course

Introduction to Python

DataCamp Course Completion

Take a look at all the courses I’ve completed on DataCamp.

My Work Experience

Where I've interned and worked during my career.

MHRA | Jun 2011 - Present

Pharmaceutical Assessor & Internal Auditor

My current responsibilities include: • Responsible for scientific evaluation of quality data for established and new active substances, abridged generic products and post-approval variations for the UK and EMA within required timescales • Managing own workload working in conjunction with service coordinators and other assessors, where necessary, to meet European, Agency or Divisional deadlines • Promptly updating Agency, divisional or team work management databases to reflect the progress of own work • Liaising with other team members in order to progress associated applications appropriately. • Providing ad hoc advice to colleagues in the division or Agency • Extending skills and knowledge in relevant regulatory and scientific or professional areas by attending relevant courses. • Contribute to assessment policy, practice, and divisional procedures. • Develop good working relationships with colleagues and with internal and external stakeholders as well as dealing effectively with official correspondence to agreed timelines • Using own and Agency resources in line with Agency and divisional strategy to meet targets. Complaince with regulatory guidance, internal auditing, and data cleansing
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MHRA | Jun 2009 - Jun 2011

Pharmaceutical Assessor - Variations

Key responsibilities and result areas • Conducting compliance assessment and update the Sentinel database for new Marketing Authorisations of European (ECRDP, MRDCRP) and national procedures, within a high level and operational target times. • Conducting quality assessment for informed consent applications to the highest standards within the operational target times. Assessing the responses received to ensure any outstanding queries have been answered satisfactorily. •Using specialist analytical training to interpret data and assess the validity of proposed variations. •Assessing national informed consent applications (BROMI). • Maintaining all Agency information management systems including Sentinel PL case folders with up to date information, contributing to the accuracy of the Sentinel database and comply with Data Assurance Protocol and relevant standard operating procedures. • Assessing the labelling and patient information leaflet, to ensure compliance with the European and national requirements including a correct depiction of the Braille, blue box information and compliance of the patient information leaflet against the readability report.

Jenny Hammond Primary School | Sep 2008 - Present

School Governor

- Working with the senior leadership team to ensure that the children at the school get the best possible education, that they will be happy and safe and enjoy their time at school. - Supporting and rigorously challenging the head teacher where necessary to ensure that objectives are delivered. - Chairing meetings, participating in the evaluation of complaints against staff and schools. - Conducting the performance review of the head teacher

MHRA | Oct 2007 - Jun 2009

Pharmaceutical Assessor

Key responsibilities and results areas: • Assessment of initial applications of parallel import licenses, including confirmation of the therapeutic equivalence of the UK and imported product and evaluation of proposed labels and leaflets. • Assessment of variation applications to update pharmaceutical aspects of licenses. • Analytically interpret available information on the imported product to determine acceptability. • Working collaboratively with other assessors and management to address technical issues arising from assessment of medicines. • Communication with applicant companies as required to correct submitted documents. • Maintenance of MHRA information systems with complete and auditable records of the assessment process. • Consultation with internal and external expertise as required (e.g. European Regulatory authorities). • Providing advice and guidance internally and to external stake holders, presenting and facilitating at workshops. • Taking action to reduce newly identified risks associated with medicines by applying professional knowledge to update and/or vary granted licences as appropriate. • Independently assess patient information and supporting user testing data with regards to leaflets and compile user-testing, compliance and bridging reports confirming appropriateness. • Using available data sources, as well as requesting additional data from other European Regulatory authorities to determine safety and resolve complex queries. • Providing clear and reliable pharmaceutical and regulatory advice to complex queries or complaints as required. • Ensuring the quality of data held within Sentinel by adhering to the Data Assurance Protocol and following the SOPs relevant to data quality and integrity. Ensuring quality assurance in the data handling, to avoid new errors being introduced into the system.

The Co-operative Pharmacy | Jul 2006 - Oct 2007

Pharmacy Manager

Managed busy healthcare based pharmacy with on average 600 items a day, also included scripts and management of medicines for local nursing home. General staff recruitment and training (including 3 members of staff up to NVQ level 3) Generated increased script volume through MDS scheme Increasing OTC sales, conducted MUR's.

The Co-operative Pharmacy | Jul 2005 - Jul 2006

Pre registration Pharmacist

General dispensary duties Recruiting and training new members of staff Managing OTC stock Liasing with local surgeries

My Education

Take a look at my formal education

Master of Pharmacy, PharmacyUniversity of Sunderland | 2005
Pharmacology BSc Hons, ScienceUniversity of Sunderland | 2001

About Me

I'm interesting in software and artificial intelligence assisted medical devices.

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