Pharmacovigilance Associate - Japanese fluency required

at  PrimeVigilance

Praha, Praha, Czech -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate27 May, 2024Not Specified01 Mar, 2024N/ADelegation,Issue Management,Communication Skills,Biotechnology,Biology,ChemistryNoNo
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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 PV Associate should be a Life science / bio medical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc.) This is an opportunity for new graduates to start and develop their career within drug safety. The PV Associate will be working as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.
If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them

Responsibilities:

  • Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines, focusing on triage, data entry, quality review and submissions workflow steps.
  • Reconciliation activities for all types of received reports
  • Works under supervision and mentoring of more experienced colleague

QUALIFICATIONS

  • Life science / biomedical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science), previous experience is not required.
  • People who are excited to learn and contribute to patient safety
  • Time and issue management, delegation, organization and multitasking skills with good attention to detail
  • Strong interpersonal and communication skills
  • Advanced English skills and Fluency in Japanese language
    Additional Information

Responsibilities:

  • Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines, focusing on triage, data entry, quality review and submissions workflow steps.
  • Reconciliation activities for all types of received reports
  • Works under supervision and mentoring of more experienced colleagu


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Biology

Proficient

1

Praha, Czech