Description
Goal:Develop and assist in leading cross-functional signal detection/safety surveillance, clinical risk management, core safety information, and aggregate report best practices for company products.Essential Functions and Duties:
- Lead and/or participate in the preparation and maintenance of Reference Safety Information (RSI), periodic reports and associated product labeling (e.g., Company Core Safety Information (CCSI), Investigator Brochure (IB), national labels, Informed Consent (ICF), Periodic Safety Update Report (PSUR) for BioMarin marketed and investigational products), clinical study reports/synopses, New Drug Application (NDA)/Biologics License Application (BLA)/Common Technical Document (CTD) submissions, Risk Management Plans and other documents as needed
- Lead and/or participate in Safety Management Team (SMT) and Product Safety Committee (PSC) meetings
- Lead the production and/or contribute to health authority and other safety related query responses
- Able to mentor and coach others at more junior levels
Requirements:
- Degree in Medicine, Pharmacy or Nursing
- Minimum of 5 years of Pharmacovigilance experience; with previous signal detection/safety surveillance and international experience preferred
- Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data to both healthcare professionals (HCPs) and non-HCPs Thorough understanding of the drug development process and context applicable to safety surveillance activities
- Strong time management, prioritization, organizational and multitasking skills are required
- Proficiency in Microsoft Office and experience with safety databases; Argus experience is a plus
To find out more about Real please visit www.realstaffing.com