Posted to MedZilla on 9/23/2018


Randstad Pharma

Pharmacovigilance 20285-MZ


 
 

Job Title: Safety Physician I (GPV)

Position Description

  • Participate in or lead safety management teams for clinical programs;
  • Serve as the safety point of contact to other colleagues (Regulatory Affairs, Quality Assurance, Medical Affairs);
  • Have the ability to participate in bridging communications between business and safety to ensure appropriate safety context is conveyed.

Position Responsibilities

  • Create regulatory reports and analytical papers, gathering and categorizing data, providing initial medical analysis and/or overall benefit/risk.
  • Create, or assist in creating:

    1. PBRERs, DSURs, PADERs;
    2. Signal detection activities;
    3. Create and/or review safety portions of submission documents.

Position Requirements

  • Physician with relevant, hands on safety experience.
  • At least 3 years of hands on PV experience in clinical and/or post marketing.
  • Solid understanding of regulations impacting Pharma industry in the US and globally, especially drug safety/ PV.
  • Hands on experience writing/reviewing Aggregate Reports , e.g., PBRERs, DSURs, and PADERs.
  • Hands on experience with signal detection activities such as analyzing/categorizing/ assessing data.
  • Strong leadership skills.
  • Excellent oral and written communication skills.
  • Excellent listening and comprehension skills.
  • Ability to work effectively in a matrix setting to resolve issues and achieve common goals.

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

Please visit our website at www.randstadpharma.com

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.