Specialist, PV Partner Management
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Holbæk
Pharmacosmos is looking for a Specialist, PV Partner Management to join our Drug Safety department, and to work closely with the Director, QPPV Office to manage PV Partners including PV partner agreements, to further develop our post-marketing pharmacovigilance system and ensure regulatory compliance.
The Drug Safety department is part of R&D at Pharmacosmos. We are a small group of four experienced and dedicated colleagues, managing global drug safety for our human and veterinary products. We are looking forward to welcoming you as an important part of the team in a progressive and innovative pharmaceutical company. You will work closely together with internal stakeholders such as R&D, Quality & Regulatory Affairs, Medical Affairs, Sales & Marketing, as well as with our external collaboration partners across the world.
You will be responsible for:
The position reports to Head of Drug Safety and QPPV.
As a professional, we expect you to:
As a person we expect you to:
Rekrutteringskompagniet A/S is responsible for the recruitment process on behalf of Pharmacosmos A/S. Further information about the position can be obtained by contacting Partner Berit Tops, on +45 2174 2322 (after February 24, 2020) or Researcher Sasja Winther, on + 45 8119 2939. Your application and CV (in English) should be submitted to us as soon as possible and no later than March 9, 2020.
About the team
The Drug Safety department is part of R&D at Pharmacosmos. We are a small group of four experienced and dedicated colleagues, managing global drug safety for our human and veterinary products. We are looking forward to welcoming you as an important part of the team in a progressive and innovative pharmaceutical company. You will work closely together with internal stakeholders such as R&D, Quality & Regulatory Affairs, Medical Affairs, Sales & Marketing, as well as with our external collaboration partners across the world.
Key responsibilities of the Specialist, PV Partner Management
You will be responsible for:
- Development, maintenance and implementation of global Pharmacovigilance Agreements (PVA)
- External liaisons with global PV partners
- Ensuring Partner Management oversight and compliance
- Maintenance of PV Partner Management and PVA SOPs, templates and systems
- Monitoring compliance according the PVAs
- Quality assurance activities related to PVA implementation in close partnership and alignment with respective in- and external stakeholders
- Ensuring compliance of in- and external pharmacovigilance e-learning training
- Supporting the development of processes for post marketing pharmacovigilance, e.g.:
- QPPV oversight
- Collection of data for the PSMF
- Deviation and CAPA management
- Operational support to the production of scientific reports (PSURs etc.)
- Acting as back-up for case processing including QC and submission of cases
The position reports to Head of Drug Safety and QPPV.
About you
As a professional, we expect you to:
- Have a relevant degree at BSc or MSc level, preferably in pharmacy, human biology, nursing, or maybe a background as pharmacy technician
- Have experience min. 3-5 years from the life science industry in a pharmacovigilance/drug safety/safety surveillance function or maybe from the regulatory authorities/drug agencies.
- Have good knowledge of PV system and GVP modules
- Experience with Pharmacovigilance Agreements and PV partner management is an advantage
- Experience with drug safety databases and/or document management systems is an advantage
As a person we expect you to:
- Be pro-active, self-driven, well organized and with good oversight
- Have a positive energy, good interpersonal skills, and able to build sustainable business relations
- Be a team-player as you will be part of a small team, but at the same time fully capable of assuming responsibility for your own tasks
- Work effectively and be flexible in a fast-paced environment with changing priorities
- Have an eye for detail, accuracy and quality
- Be an excellent communicator, fluent in English, both written and spoken
We offer
- An opportunity to join a small pharmacovigilance team with great humor, where you will take part in a wide variety of pharmacovigilance tasks
- Cross-functional and cross-cultural collaboration with colleagues and PV partners
- Opportunity to be part of Pharmacosmos’ inspiring working environment and continued global growth
- Flexible working environment supported by modern communication technology usages
- An exciting and challenging role where you can develop your personal and professional competencies
Additional information
Rekrutteringskompagniet A/S is responsible for the recruitment process on behalf of Pharmacosmos A/S. Further information about the position can be obtained by contacting Partner Berit Tops, on +45 2174 2322 (after February 24, 2020) or Researcher Sasja Winther, on + 45 8119 2939. Your application and CV (in English) should be submitted to us as soon as possible and no later than March 9, 2020.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Holbæk.
Jobbet er oprettet på vores service den 10.2.2020, 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.
- Øvrige
- Holbæk
- Mandag den 09. marts 2020
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