QPPV Office Associate
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Holbæk
Do you thrive with structure and keeping good oversight of tasks? Are you quality- and detail-oriented by nature? Would you like to use these competencies to contribute to patient safety in an innovative pharma company?
The QPPV Office is part of Global Drug Safety Department within the Pharmacosmos R&D organisation. Our primary focus is to ensure the patients safety accurately and timely, in accordance with regulatory requirements. We are a team of experienced and dedicated professionals within Global Drug Safety Department, managing global drug safety for our human and veterinary products. You will become an important part of the QPPV Office team, working with a wide range of regulatory and quality management tasks.
The business unit is driven by a high level of professionalism, an open-minded approach, where everyone contributes to knowledge sharing, a fun working environment and friendly atmosphere.
As our new QPPV Office Associate you will have an independent role with a wide variety of operational tasks and responsibilities, dependent on your level of experience. You will work closely with your colleagues across Global Drug Safety Department, managing quality and compliance related tasks, including maintaining pharmacovigilance system master files. You will be in regular contact with internal stakeholders, as well as with our affiliates and external collaboration partners across the world.
The position reports to the Director, QPPV Office.
Contribute to compliance monitoring
You have a relevant background preferably within natural/health related sciences, such as pharmaconomist, nurse, health care coordinator, or maybe laboratory technician.
Preferably you have a few years of experience from a pharmaceutical, medical device or biotech company, or from regulatory authorities, where you have worked with pharmacovigilance, quality assurance/quality control, or manufacturing/production/logistics in a GXP regulated function.
It is key to us, that you have a strong quality mindset, and work in a structured and organised manner.
As a person, we expect you to:
As a professional, we expect you to:
ONTOPS Recruitment & Development is responsible for the recruitment process on behalf of Pharmacosmos A/S. Further information about the position can be obtained by contacting Recruitment Partner Berit Tops, on +45 2174 2322 or [email protected] (due to summer holidays, you may expect delay in response time during weeks 29-31). Your application and CV (in English) should be submitted as soon as possible and no later than August 16, 2023
About the team
The QPPV Office is part of Global Drug Safety Department within the Pharmacosmos R&D organisation. Our primary focus is to ensure the patients safety accurately and timely, in accordance with regulatory requirements. We are a team of experienced and dedicated professionals within Global Drug Safety Department, managing global drug safety for our human and veterinary products. You will become an important part of the QPPV Office team, working with a wide range of regulatory and quality management tasks.
The business unit is driven by a high level of professionalism, an open-minded approach, where everyone contributes to knowledge sharing, a fun working environment and friendly atmosphere.
About the job
As our new QPPV Office Associate you will have an independent role with a wide variety of operational tasks and responsibilities, dependent on your level of experience. You will work closely with your colleagues across Global Drug Safety Department, managing quality and compliance related tasks, including maintaining pharmacovigilance system master files. You will be in regular contact with internal stakeholders, as well as with our affiliates and external collaboration partners across the world.
The position reports to the Director, QPPV Office.
key responsibilities
Contribute to compliance monitoring
-
- QC of KPIs
- Overview of PV Training Statistics
- Trending of Deviations
- Coordinate Change Management procedures
- Perform Regulatory Surveillance
- Maintain Standard Operating Procedures (SOP)
- Contribute to the maintenance of the Pharmacovigilance System Master File (PSMF)
- Administrative Departmental tasks
- Data/tracker overview
- Involved in Audits and Inspections
- Assist with CAPA development.
About you
You have a relevant background preferably within natural/health related sciences, such as pharmaconomist, nurse, health care coordinator, or maybe laboratory technician.
Preferably you have a few years of experience from a pharmaceutical, medical device or biotech company, or from regulatory authorities, where you have worked with pharmacovigilance, quality assurance/quality control, or manufacturing/production/logistics in a GXP regulated function.
It is key to us, that you have a strong quality mindset, and work in a structured and organised manner.
As a person, we expect you to:
- Thrive with structured work tasks
- Be open for collaboration with both internal and external stakeholders
- Be pro-active, self-driven, well organised and with good oversight
- Have a positive energy, good interpersonal skills, good sense of humor and able to build sustainable business relations
- Have an eye for detail, accuracy, and quality
- 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
- Be an exact and precise communicator
As a professional, we expect you to:
- Be fluent in English (professional level), both written and spoken
- Be independent, strong analytical and problem-solving skills
- Have a good sense and awareness of regulations and policies
- Be able to work under time pressure in a changing environment with flexibility
- Have a strong sense of responsibility and accountability
we offer
- An opportunity to join a small and dedicated pharmacovigilance team with great humour, and an open and friendly atmosphere
- Cross-functional and cross-cultural collaboration with colleagues and global PV partners
- An independent function in global settings, with a wide variety of pharmacovigilance tasks and responsibilities
- Inspiring and flexible working environment.
- An exciting role where you can develop your personal and professional competencies and contribute to Pharmacosmos' continued global growth.
- An attractive and competitive compensation package.
Additional information
ONTOPS Recruitment & Development is responsible for the recruitment process on behalf of Pharmacosmos A/S. Further information about the position can be obtained by contacting Recruitment Partner Berit Tops, on +45 2174 2322 or [email protected] (due to summer holidays, you may expect delay in response time during weeks 29-31). Your application and CV (in English) should be submitted as soon as possible and no later than August 16, 2023
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 27.6.2023, 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
- Onsdag den 16. august 2023
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