Corona betød en stor omvæltning for manges arbejdsliv. Men ikke for vores, for vi fortsatte bare det, som vi havde gjort siden vi overtog Billev Pharma i 2015, men nu i meget højere grad.
Vores medarbejdere havde i forvejen mulighed for mindst 1 hjemmearbejdsdag om ugen og nogle endda op til 4 dage, afhængig af ønsker, bopæl og livssituation. Den 11. marts efter statsministerens pressemøde tog det os mindre end en halv time at rykke alle til hjemmearbejde på fuld tid. Selv vores firmatræning i Pilates blev nu rykket online.
Vi havde allerede en velfungerende it-infrastruktur, der er nødvendig for et effektivt og problemfrit samarbejde med vores kunder og hinanden hjemmefra eller fra hvor som helst.
Vores 5 års erfaring med hjemmearbejde og fleksible arbejdsforhold har betydet, at vi har kunne fortsætte med at hjælpe vores kunder, uden at slække på vores stærke faglige miljø, høje kundeservice, effektivitet eller vores arbejdsglæde. Vi fortsatte bare.
Vi søger en erfaren Regulatory Affairs Manager, som hurtigt vil kunne arbejde selvstændigt med opgaverne. Ved du en masse om CTD, eCTD og mere specifikt om et eller flere af modulerne 1-3? Du skal indgå i et team med dygtige kollegaer. Vi tilbyder alsidige opgaver, en arbejdsplads med få møder og fleksible arbejdsforhold. Måske drømmer du om nedsat tid? Kunne du tænke dig at arbejde hos os i Billev Pharma? Så kontakt os.
Maria Brogaard is our state-authorised translator who has been with us for more than 15 years. Maria provides high-standard translations and proofreading of product information and all other documents in connection with regulatory procedures and pharmacovigilance in an environment where deadlines are often extremely tight. Her work receives extraordinarily positive acknowledgement from the health authorities.
Maria is a qualified user of
the SDL Trados Studio and efficiently handles complex translation projects. It
goes without saying that all her translations are performed in compliance with QRD
templates and national guidelines. Also, research of background sources and the
four-eyes principle are vital elements of the translation process.
Some of our clients previously
used other translation services which in the short run may be less expensive.
They turn to Maria because of her high-grade translations as they have realised
that poor-quality translations and non-conformity with templates and guidelines
delay the entire procedure and the time to market.
Maria is one of the most
experienced and most talented translators within her field – we are lucky to
have her in our team.
In February 2019 Susanne Thiilborg,
Ph.D.Pharm., began a position as Regulatory Affairs Manager with Billev Pharma.
Susanne has more than 20 years’ experience within analytical chemistry from the
pharmaceutical company Lundbeck.
Susanne accounts for all
possibilities and reviews the relevant issue from all aspects before drawing a conclusion.
With her extensive experience Susanne
can help you with writing and reviewing the
regulatory documentation for clinical trials (IMPD, IND), initial MAA/NDAs or maintenance activities such
as variation applications. Also, she is able to assist you with compliance
projects identifying and cleaning up GAPs in your quality documentation.
We are happy that Susanne has joined our company. With Susanne on
our regulatory team we now cover all areas within regulatory affairs.
We are happy to announce the promotion of Charlotte Lindorf Eriksen and Sana Iqbal from Officer to the position of Manager. Charlotte and Sana have been with us for 4 years and have both shown an impressive ability to upskill rapidly.
we celebrated Billev Pharma’s 40 years anniversary and also 3 times 10th anniversaries.
Skaarup Pedersen has been with us since 2008. Mette’s key area is proofreading
and translation. Mette is highly respected among our clients for her eye for
details – she is always willing to give a helping hand and a friendly smile.
also been with Billev Pharma for 10 years. We are proud to witness the
expansion of the Billev Pharma team while aiming at providing our clients with
useful and reliable support within the fields of regulatory affairs,
pharmacovigilance and quality.
Ulrikke, Directors and Owners of Billev Pharma ApS
As of January 2020, Susanne Thiilborg and Bo Kreilgaard will hold the position of Senior Regulatory Affairs Manager and Lisbeth Bonde Jensen now holds the position of Senior Pharmacovigilance Manager. Lisbeth is also QPPV for one of our major accounts.
Lisbeth, Susanne and Bo have more than 20 years of experience within their respective field. You can read more about their qualifications here on our website.
Lorentzen, M.Sc. Pharm., filled the recently established post as QA Manager.
Trine has several years of solid experience with Good Distribution Practice
(GDP) and the function as Responsible Person.
Are you facing
an inspection? Are you struggling to keep your QMS up to date? Are you lacking the
capacity or qualifications to audit you contract takers or suppliers? Would you
like to have an external expert opinion during your self-inspection or audit?
determine the GAPs in your QMS and help you close them.
hosted many inspections with impressive results. She is an experienced GDP Lead
auditor and conducts her host function in a pleasant and constructive tone with
a flash of humour.
In June 2018
Karen Jensen, M.Sc. Pharm., joined our regulatory team. Karen and our
regulatory team can assist you with both European and national initial MAAs or
Karen is a generous co-worker and has more than 16 years of experience working as Special Adviser with the Danish Medicines Agency. She has a flair for quickly identifying the heart of the matter and for problem solving. Karen has excellent communication skills, also when it comes to extremely specialized topics, and it goes without saying that she strives to meet the deadline. Karen joining our team has indeed strengthened our knowledge within regulatory affairs. You can read more about Karen’s qualifications here http://billevpharma.dk/employees/karen-jensen/