Konsulenter i en Coronatid

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 erfaren Regulatory Affairs Manager – Stillingen er besat

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.

Poor-quality translations may delay your time to market

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.

You can read more about Maria’s qualifications on our website http://billevpharma.dk/about-2/staff/

We now cover all areas within regulatory affairs

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.

You can read more about Susanne’s qualifications on our website http://billevpharma.dk/about-2/staff/

Anniversaries in 2018

In 2018 we celebrated Billev Pharma’s 40 years anniversary and also 3 times 10th anniversaries.

Mette 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.

We have 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.

Anja and Ulrikke, Directors and Owners of Billev Pharma ApS

Vi søger erfaren RA specialist

Vi søger specialist til vores RA team, som hurtigt vil kunne arbejde selvstændigt med opgaverne. Har du flere års erfaring med registrering? Søger du nye udfordringer? Ved du en masse om vedligeholdelse af registreringer for humane lægemidler herunder udarbejdelse af variationsansøgninger og opdatering af produktinformation? Så kontakt os.  Vi tilbyder en arbejdsplads med få møder og fleksible arbejdsforhold.

Our team has extensive experience

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.

Our regulatory team

As of January 2020, Karen Jensen will hold the position as Head of Regulatory Affairs and Charlotte Munk Ejlersen now holds the position as Senior Regulatory Affairs Manager.

Karen and Charlotte, together with the rest of our regulatory team, achieve high quality output and have specialized qualifications within all fields of regulatory affairs.

On 30-31 January you have the opportunity to meet Karen in Amsterdam at the Regulatory Affairs conference arranged by Medicines for Europe.

We started 2019 by welcoming 3 new employees in our Billev Pharma team

Trine 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?

Trine can determine the GAPs in your QMS and help you close them. 

Trine has 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.

You can read more about Trine’s qualifications on our website http://billevpharma.dk/about-2/staff/