Semina Kayani

Personal Profile:

I am independent and highly organised but also work well in a team

environment. I like variety in my work and take pleasure in constantly
learning new concepts.

Education & Qualifications:

2002-2003 Institute of Child Health, UCL, London

MRes Biomedicine

1999-2002 Aston University, Birmingham

BSc (Hons) Applied & Human Biology

1997-1999 Wycombe High School, High Wycombe, Buckinghamshire

A-Levels: Biology, Chemistry and General Studies

1993-1997 The Cressex School, High Wycombe, Buckinghamshire

GCSEs: 8 GCSE’s (A-C) including: Science, Mathematics and
English

Professional Experience

July 2008 - current

Drug Safety Associate - Covance, Maidenhead, UK

 Review SAE information received from Investigator sites for completeness

 Generate queries and forward to site for updates
 Enter information from SAEs into Argus database
 Enter expedited cases into the Eudravigilance database

Aug 2007 - July 2008

Pharmacovigilance Officer - Chiltern International, Slough, UK

 Review SAE information received from Investigator sites for completeness

 Enter information from SAEs onto in-house database and prepare safety
data reports
 Training to use Clintrace 4.1
 Submit CIOMs to clients and regulatory authorities
 Liaise with Clinical to have up-to-date contact details for Investigators and
corresponding Ethics committees
 Update tracking sheets as required and provide case details to Clinical
department
 Write SAE reporting plans for new studies
 Produce Line Listings on a period basis
 Submit Annual Safety Report to regulatory authorities
 Prepare presentation for Investigator meeting and conduct CRA training
Aug 2006- Aug 2007

Associate Data Analyst - Pharmanet, High Wycombe, UK

 Knowledge of SOPs relevant to current activities and general company

issues
 Use of in-house systems Faxsys and Websys where required for accessing
subject data
 Verification of data entered into database and discarding of duplicate data
 Perform data review and create manual DCFs for subject data
 Liaise with RMLs and site staff to provide study specific site files, CRFs
and DCFs
 Update database to solve discrepancies
 Participate in the completion of all quality control measures necessary for
the finalisation and transfer of the database and related materials to the
sponsor

Mar 2004 - Aug 2006

Research Scientist (Immunology) - Oxxon Therapeutics, Oxford

 Preparation and cryopreservation of PBMC from Buffy coat packs and

melanoma patient samples
 Enter details of blood preparation carried out at clinical sites onto the
sample tracking database and use the information to organise shipments
of samples back to Oxxon
 Liaise with members of clinical team to resolve sample queries, shipment
logistical issues and protocol deviations
 Conduct IFN-γ ELISpot analysis for the analysis of melanoma specific T-cell
responses in patients over the time course of treatment in different
treatment groups
 Organised batch testing of FCS for general use within the research
departments
 Wrote COSHH assessments for chemicals and reagents used within the
research departments
 Assist in completing the melanoma clinical trial report which involved
generating datatables, formatting and cross checking all work for
accuracy
 Presentation of clinical immunology data to company members

Apr 2003 - Sept 2003

ICH- Research Student, Surgery Unit, UK

 Investigated the oxidative damage to Carnitine Palmitoyl Transferase I

and other proteins in neonatal sepsis
 Immunoprecipitation of proteins from control and septic mitochondria was
followed by western blotting to determine which specific proteins had
been modified
 Protein separation conducted by gel electrophoresis followed by western
blotting and silver staining. After optimisation, bands corresponding to
CPT-I were excised, digested and analysed by MALDI-TOF

Jan 2003 - Apr 2003

ICH- Research Student, Molecular Immunology Unit,

 Investigated the presence of lipid rafts in dendritic cells and their effect
on cell migration
 Carried out primary cell culture and human monocyte derived Dendritic
cells were phenotyped using FACs analysis
 Immunofluorescent staining of the actin cytoskeleton was carried out and
confocal images were obtained
 Motility experiments were carried out using a Dunn chamber. Openlab
3.03 software was used to record the time lapse images

Jan 2002 - Apr 2002

Research Student - Cancer Biochemistry Unit, Aston University, UK

 Project title ‘Bombesin, CCK antagonists and breast cancer: the effects on
mitosis and steroid metabolism.’
 The MCF-7 breast cancer cell line was grown and the number of cells
present determined by counting nuclei using a Coulter Counter
 17β hydroxysteroid dehydrogenase activity and Phosphatidylinositol
hydrolysis was measured using liquid scintillation counting

Jun 2001 - Sept 2001

Laboratory Technician - Amersham Plc, Little Chalfont, UK

 PowerPoint presentation and seminar on pulmonary embolisms followed

by a discussion on the anticoagulation treatments available at present
 Involved in the welfare of the animals; ensuring they have adequate food
and are comfortable in their environment

Skills and achievements:

 I have presented SAE processing procedures at an Investigator meeting

 I have received training in the fundamentals of clinical trials, an

introduction to ICH GCP and fundamentals of GCP

 I have participated in various in-house training programmes, which have

included workshops on intellectual property, good manufacturing practise
and most recently a writing course.

 I participated in a residential skills development course and furthered this

by attending a facilitation training course

 I attended a Bioinformatics course where I was taught how to utilise

Bioinformatics tools for sequence and structural analysis, and molecular
modelling

 Computer packages I can use confidently are Word, Excel, PowerPoint,

Access, Outlook, Lotus notes, Reference Manager, Adobe Photoshop and
Prism