Our RA team is growing and continues to in 2021…

Anne Ravnholdt Høcker joined Billev Pharma’s RA team in September. Anne has more than 20 years’ experience with writing and reviewing analytical and pharmaceutical documentation for MAAs and variations. 

Anne had a strong wish to work part-time but at the same time she did not want to miss out on the challenging tasks. Now she is working four days a week and we trust that we can live up to her specialist expectations with diverse regulatory projects from our clients working in the area of small molecules and radiopharmaceuticals.

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

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

Our RA team continues to grow

In February Trine Fabricius Holm, M.Sc. Pharm., joined our regulatory team. Trine has more than 18 years of experience working as a Regulatory Project Manager from the Danish Medicines Agency. Trine has wide experience with national and European procedures. Trine joining us has indeed strengthened our RA team. You can read more about Trine’s qualifications here on our webpage.

10 years anniversary

Our highly valued colleague Majbritt Eichmeier Hansen has been with us since March 2011 so this year we are celebrating her 10 years anniversary.

Majbritt began her career in Regulatory Affairs, today she specialises in Pharmacovigilance. In 2015 Majbritt was promoted to Head of our Pharmacovigilance team.

In July 2012, when the current Pharmacovigilance legislation came into effect, Majbritt showed an excellent ability to implement legislation in daily practice and thus ensuring compliance for our clients. Today, she is using the same skills when implementing the new Veterinary Medicines Regulation which becomes effective January 2022. Majbritt is QPPV for Billev Pharma’s human and veterinary pharmacovigilance system. Last year Majbritt was qualified as Pharmacovigilance Lead Auditor and she currently performs 5-10 Pharmacovigilance audits per year.

We are lucky to have Majbritt in our team.

Promotion

We are happy to announce the promotion of Katrine Schuster Ovesen from Officer to the position of Regulatory Affairs Manager.  Katrine has been with us for 6 years, starting as a student worker. She has shown an impressive ability to rapidly upskill her competences within the regulatory field, such as variation applications to all European countries and the UK as well as electronic submission requirements to the USA and Canada.

You can read more about Katrine’s qualifications here on our webpage.

Extension of our RA team with an experienced Regulatory CMC specialist

Karina Rebild joined Billev Pharma as a Regulatory CMC Specialist in August. With her more than 30 years’ experience – including sterile production and regulatory lifecycle management – she brings valuable knowledge to our RA team, which currently counts 15 colleagues. Karina is mainly working for our new major client. The client has chosen to outsource some of their regulatory work to us based on the wide-range knowledge and experience in our Regulatory Affairs Specialist Team and our highly scientific work environment with professional back-and-forts.

You can read more about Karina’s qualifications here http://billevpharma.dk/about-2/staff/

Vi søger erfaren RA specialist – Stillingen er besat

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.