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.

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/

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.

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.

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.

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.

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.