Daria Bilan
Code Approval Technical Review Manager
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About
My main strengths: attention to detail; well-organised; desk research skills; excellent team-worker and trainer; creative flair; initiating changes to improve procedures.
Experience
Code Approval Technical Review Manager at Jazz Pharmaceuticals (2023-04 – Present)
- Completed AQP training
- Review promotional and non-promotional materials in Veeva PromoMats
- Introduced a weekly prioritisation meeting for asset owners and reviewers
- Open-door policy with document owners to answer any questions / concerns through the review process
- Create supporting documents to enable a more consistent and compliant approach across Jazz: Referencing Guide; Document Owners' Guide; working instructions
- Have collaborated with colleagues from different departments to create guidance documents e.g. briefing document, instructions for data entry into a database of HCP engagements (to enable compliance sign-off)
- Instrumental in suggesting and enabling the use of a QR code for prescribing information and the use of core claims in Veeva PromoMats
- Organised training for the team e.g. copyright and the use of binders in Veeva PromoMats
- On my own initiative, created a Teams channel for the supporting documentation which grew into an intranet page which I update.
Senior Medical Information Specialist at Ethypharm (2021-12 – 2023-03)
- Reviewed promotional materials; set up weekly job bag meetings
- Medical information enquiries; compiled an FAQ Excel spreadsheet.
Medical Information Specialist at CNX Therapeutics Ltd. (2021-04 – 2021-12)
- Answered escalated enquiries using the IRMS database; updated standard letters; wrote FAQs
- Liaised with the outsource provider; quality checked their responses.
Medical Information Officer at Flynn Pharma (2020-09 – 2021-03)
- Raised the Medical Information Service to a professional level
- Answered primary and secondary enquiries by the telephone or e-mail; literature searching
- Wrote and presented a pharmacovigilance training course to the sales representatives – designed an adverse event reporting card for them
- Updated and added SmPCs and PILs to the EMC website
- Took unlicensed product order form into Medical Information responsibility – away from Reception
- Worked through a Pharmacovigilance audit.
Medical Copy Approval Specialist – Compliance at Indigo Medical (2020-03 – 2020-08)
- Reviewed materials, mainly within the respiratory therapy area, using Veeva.
Technical Reviewer at Otsuka (2019-10 – 2020-02)
- Reviewed promotional / non-promotional company materials for schizophrenia / kidney disease therapy areas using ZINC to ensure alignment with the ABPI Code of Practice.
Medical Compliance Specialist at AstraZeneca (2017-06 – 2019-09)
To improve the quality of materials, I helped document owners and external agencies by:
- Reviewed promotional / non-promotional materials for respiratory and vaccination products using Veeva PromoMats
- Processed HCP forms (HCP engagements outside the UK)
- Trained staff on technical review and the basics of the ABPI Code of Practice
- co-writing an in-house referencing guide; this was turned into a global training package
- creating a spreadsheet with references to ensure consistency and accuracy
- creating a document owner's checklist to be used before materials were uploaded to be reviewed.
Clinical writer at Prism Ideas (2017-01 – 2017-04)
- Wrote clinical study reports.
Medical Information Specialist at Roche (2014-09 – 2017-01)
- Answered second-tier enquiries on rheumatology, respiratory, multiple sclerosis and established products; liaised with Quality and Regulatory departments, as necessary; wrote standard responses
- Reported adverse events and quality issues with medicines
- Trained a medical manager on a summary of product characteristics; she liked my training style so much that she asked me to train her on another medicine
- Presented to sales representatives about Medical Information
- On my own initiative, wrote and presented training on literature searching.
Medical Information Scientist at Grunenthal (2014-02 – 2014-08)
- Answered Medical Information enquiries; reviewed materials for opioid analgesics
- Presented writing tips at Medical Science Liaisons' (MSL) meetings to improve standards.
Medical Information Scientist at Bayer (2012-05 – 2014-01)
On my own initiative
- Copy approval of promotional / non-promotional materials
- Answered external Medical Information enquiries on the telephone, through e-mail or post on the company's pharmaceutical products; logged these enquiries on MedInfoSys database; wrote responses – both original ones and used standard letters / FAQs
- Carried out literature searches; liaised with internal departments such as Drug Safety
- Carried out adverse event checking in the MedInfoSys database, as required
- Reported product technical complaints and adverse events
- Wrote standard letters for the contrast media products
- compiled adverse event reporting forms to be filled in when answering the telephone to ensure all essential data was collected; wrote a letter approval check list for everyone to use; got agreement for the team to use a board for keeping track of ordered items; initiated sending round lunchtime telephone rota.
Information Scientist at National Clinical Guidelines Centre (2011-06 – 2012-02)
- Literature searching on medical conditions and medicines to support NHS guideline production.
Technical Data Management at Unilever (2009-07 – 2011-05)
- Co-pack Workstream Leader. Brought my idea of a questionnaire to the Workstream which was accepted as best practice; managed data entry onto a database.
Information Scientist, Unilever Information Group at Unilever (2005-08 – 2009-07)
- Answered a wide range of enquiries from scientists – from toxicology to epidemiology
- Acted as customer relations contact for the toxicology team.
Librarian at Putteridge School Library (2005-06 – 2005-08)
- General library work including shelving, cataloguing and being on the issue desk.
Medical Information Researcher, Information Services at Medicus International (2003-08 – 2005-05)
- Found key opinion leaders; literature searching; wrote executive summaries regarding therapy areas.
Information Adviser, Library Services at AstraZeneca (2001-07 – 2003-08)
- Answered external non-drug related queries; trained Medical Information team on Embase; scanned medical journals; compiled a literature alert; manned the Enquiries desk; catalogued books.
Librarian / Information Professional at Various (1990 – 2001-06)
Various jobs in libraries / information centres as a librarian / information professional.
Education
Post-Graduate Diploma in Information Science – City University (1991 – 1993)
BSc. (Hons.) in Biochemistry – University of London (1987 – 1990)