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Pošalji prijatelju

Pharmacovigilance (PV) Physician (m/f)

Zagreb

Rok prijave:

We are an international fast growing healthcare company and as a result of our rapid growth we are looking for:

Pharmacovigilance (PV) Physician

PrimeVigilance is continuing to expand and is looking for a Pharmacovigilance (PV) Physician to join our dynamic and rapidly expanding organization.

The Pharmacovigilance (PV) Physician is responsible for medical review of ICSRs and literature review, supporting writing of signal detection reports, supporting writing and or reviewing of aggregate reports (DSURS, SURS/PBRERs/PADERS) as may be required by the Company or Client.

Key Accountabilities:

  • Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment
  • Support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues
  • Review and provide input in periodic reports
  • Review literature screening search strategy
  • Review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
  • Review database outputs
  • Write signal detection and evaluation reports
  • Propose a course of action whenever a new risk is identified
  • Write Pharmacovigilance procedures

Qualifications and Skills:

  • The PV Physician should be medically qualified as a physician
  • Extensive previous experience in Pharmacovigilance
  • Proven experience in writing signal detection and evaluation reports
  • Extensive Regulatory and Safety writing experience (aggregate reports, safety submission, regulatory queries, etc.)
  • Excellent interpersonal and communication skills
  • Fluent knowledge of English (written and oral) in addition to the local language

Our offer:

  • Competitive salary
  • Work within a successful, highly – qualified and dynamic team
  • Professional training and career development in a fast growing healthcare company

If you would like to be considered for this opportunity, please send your application via
application link enclosing your English CV and Cover Letter.

Due to high a volume of applications only short-listed candidates will be contacted.

Deadline for applications: 26.01.2018.

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