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Medical Reviewer I

  • Job
    Full-time
    Junior & Mid Level
  • Legal
    Healthcare
  • Pune
  • Quick Apply

AI generated summary

  • You must be a qualified physician with pharmacovigilance experience, good at planning, teamwork, and communication. Experience in aggregate reports or signal detection is a plus.
  • You will review and approve ICSRs and SAE reports, assess safety data, evaluate literature, contribute to safety reports, participate in signal detection, and propose action for identified signals.

Requirements

  • Medically qualified as a physician with demonstrated experience in Pharmacovigilance
  • Any experience in aggregate reports and signal detection is desirable
  • 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 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
  • To review and provide input in Periodic Safety Update Reports
  • To review and provide input in Development Safety Update Reports
  • Participating in signal detection activities including meetings and writing signal detection reports
  • Proposing a course of action whenever a possible signal is identified

FAQs

What is the role of a Medical Reviewer I at PrimeVigilance?

The Medical Reviewer I is responsible for reviewing and approving post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports, conducting literature screening, reviewing database outputs, and providing input for safety update reports.

What qualifications are required for this position?

The position requires being medically qualified as a physician with demonstrated experience in Pharmacovigilance. Experience in aggregate reports and signal detection is desirable.

What kind of training and development opportunities does PrimeVigilance offer?

PrimeVigilance offers training and career development opportunities internally with a strong emphasis on personal and professional growth.

Is experience in aggregate reports important for this position?

While not mandatory, any experience in aggregate reports and signal detection is desirable for the role.

What values does PrimeVigilance prioritize in its workplace?

PrimeVigilance prioritizes quality, integrity & trust, drive & passion, agility & responsiveness, belonging, and collaborative partnerships.

Is teamwork emphasized in the Medical Reviewer I role?

Yes, the ability to work effectively cross-culturally and cross-functionally, while valuing teamwork, is an important requirement for this role.

How does PrimeVigilance support work-life balance?

PrimeVigilance acknowledges that a healthy work-life balance is critical for employee satisfaction, and it invests in employee experience, well-being, and mental health.

Does PrimeVigilance promote diversity and inclusion in the workplace?

Yes, PrimeVigilance prioritizes diversity, equity, and inclusion, creating an equal opportunities workplace for people from all cultural backgrounds, genders, and ages.

What kind of working environment can I expect at PrimeVigilance?

PrimeVigilance offers a friendly and supportive working environment with the opportunity to work with colleagues from around the world, using English as the company language.

What is the significance of signal detection activities in this role?

Signal detection activities are crucial as they involve identifying potential safety signals, proposing courses of action, and contributing to overall drug safety monitoring.

Bringing expertise to deliver medicines our world can trust.

Science & Healthcare
Industry
501-1000
Employees
2008
Founded Year

Mission & Purpose

PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders and leaders have an unrivalled reputation in the sector with a network of expert associates across the world. These include former senior regulators and consultants with extensive industry experience, especially with marketed products.