PSMF Associate (Pharmacovigilance)

at  PrimeVigilance

Kraków, małopolskie, Poland -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate02 Jan, 2025Not Specified05 Oct, 2024N/AIssue Management,Pharmacovigilance,Communication Skills,Management SkillsNoNo
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Description:

Company Description
We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.
We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient’s lives.
Job Description
The position is primarily responsible for the creation, maintenance and review of client Pharmacovigilance System Master Files, in line with global regulations, legislation, PrimeVigilance and Client requirements.

The position will maintain and manage PSMF for clients, activities will include PSMF:

  • Authoring
  • Revision
  • Quality check review
  • Tracking
  • Attend regular PSMF meetings with internal employees and Clients.
  • Fulfilment of tasks assigned by the Line Manager.
  • Provision of training in PSMF area.
  • Revision and update of PSMF related quality documents.

Qualifications

  • Degree qualification preferred, ideally in life sciences - pharmacy, nursing or other healthcare related qualification
  • Some experience/knowledge of Pharmacovigilance is required.
  • Organisational skills, including attention to detail and multi tasking.
  • Management skills, including time and issue management
  • Excellent communication skills

Additional Information

Responsibilities:

Please refer the Job description for details


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Life sciences pharmacy nursing or other healthcare related qualification

Proficient

1

Kraków, małopolskie, Poland