QPPV Office Manager
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Holbæk
Pharmacosmos is looking for a QPPV Office Manager to join our Drug Safety Team and take part in developing our post-marketing pharmacovigilance system further and ensure regulatory compliance. In Drug Safety we are a small group of 4 dedicated employees, and you will become an important part of the team in a progressive and innovative pharmaceutical company. Drug Safety is part of R&D at Pharmacosmos.
In collaboration with the Director, QPPV Office you will be responsible for:
Support the development of processes for post marketing pharmacovigilance such as:
Further information about the position can be obtained by contacting Head of Drug Safety, Jens Peter Balling on phone +45 27888872. Your application and CV in English should be submitted soon as possible and no later than 10 January 2020.
Key responsibilities of the QPPV Office Manager
In collaboration with the Director, QPPV Office you will be responsible for:
- Preparation and maintenance of Pharmacovigilance Agreements
- Partner Management incl. partner oversight and compliance
- Ensuring compliance of internal and external Pharmacovigilance training
- Prepare compliance data and keep compliance trackers
- Ensuring that standard operation procedures (SOPs) are in place and maintained
- Reconciliation of ICSRs with partners
- Compliance monitoring of procedural and regulatory obligations
Other responsibilities
- Act as back-up for case processing including QC and submission of cases
Support the development of processes for post marketing pharmacovigilance such as:
- Further develop processes for compliance monitoring
- Be part of the team defining key performance indicators
- Support QPPV oversight
- Support the process for collecting data for the PSMF
- Monitor and further develop training programs
- Deviation and CAPA management
- Provide operational support to the production of scientific reports (PSURs etc)
Education
- A degree preferably in pharmacy, nursing, biological sciences and/or relevant experience from similar job
Skills
- Excellent overall communication skills with advanced oral and written English skills
- Advanced computer skills
- Independent, strong analytical and problem-solving skills
- Good sense and awareness of regulations and policies
- Ability to work under time pressure in a changing environment with flexibility
- Experience with Pharmacovigilance Agreements is an advantage
- Strong sense of responsibility and accountability
- Preferably 5 years of pharmacovigilance experience
- Team player
We offer
- To be part of a great team in a small pharmacovigilance unit
- Close cooperation with our colleagues in Regulatory Affairs, R&D, Medical Affairs, Sales etc.
- Possibility to take part in a wide variety of pharmacovigilance tasks
- Further develop your skills by taking ownership and responsibility
- Flexible working environment supported by modern communication technology usages
Additional information
Further information about the position can be obtained by contacting Head of Drug Safety, Jens Peter Balling on phone +45 27888872. Your application and CV in English should be submitted soon as possible and no later than 10 January 2020.
Information og data
Denne ledige stilling har jobtypen "Kontorassistent", og befinder sig i kategorien "Kontor, handel og service".
Arbejdsstedet er beliggende i Holbæk.
Jobbet er oprettet på vores service den 5.12.2019, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Kontorassistent
- Holbæk
- Fredag den 10. januar 2020
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