PV Physician II

ERGOMED Logo

ERGOMED

📍Remote - Bulgaria

Summary

Join PrimeVigilance, a global leader in pharmacovigilance, as a Pharmacovigilance (PV) Physician II. You will play a key role in medical reviews of ICSRs and literature, signal detection reporting, and contributing to aggregate reports. This position requires a medical background and demonstrated experience in pharmacovigilance and clinical settings. Excellent interpersonal, communication, and presentation skills are essential. PrimeVigilance offers training, career development, a supportive environment, and opportunities for global collaboration. The company prioritizes diversity, equity, and inclusion, and values a healthy work-life balance. Join our team and make a positive impact on patients' lives.

Requirements

  • The PV Physician should be medically qualified as a physician with demonstarted experience in PharmacoVigilance and working in a clinical setting
  • Excellent interpersonal skills
  • Ability to plan, organise, prioritise and execute multiple tasks
  • Ability to work effectively cross culturally and cross functionally and value the importance of teamwork
  • Communication skills
  • Presentation skills

Responsibilities

  • To review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. Review includes coding, assessment of seriousness, listedness/expectedness and Company causality, as well as writing of Company comment, follow-up questions and Analysis of Similar Events, when required. Including completion of all required supporting documentation such as trackers
  • To support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues
  • To review and provide input in periodic reports
  • To review literature screening search strategy
  • To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
  • Reviewing database outputs
  • Can be delegated to support signal detection activities upon acquiring sufficient experience
  • Proposing a course of action whenever a new risk is identified

Benefits

  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly, supportive working environment
  • Opportunity to work with colleagues based all over the world, with English as the company language

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