Associate Medical Director

Brisbane, CA 94005

Posted: 09/27/2019 Employment Type: Contract Industry: Pharmacovigilance Job Number: 6925

Associate Medical Director

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. Seeking an Associate Medical Director -

Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving products to ensure accuracy of ICSR MedDRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting

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 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

Participate in Safety Management Team (SMT) and Product Safety Committee (PSC) meetings

Support study teams (clinical and registry) for assigned investigational and marketed products; serve as PV expert and liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities as needed

contribute to the production and/or contribute to health authority and other safety related query responses

Provides input to Pharmacovigilance policies and standard operating procedures.

Able to mentor and coach others at more junior levels


  • Minimum of 2 years of Pharmacovigilance experience; with previous signal detection/safety surveillance and international experience preferred.
  • Minimum 1 year medical/clinical experience post- graduate training
  • 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
  • Working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU) Volume 9A and Volume 10 clinical trials directive; Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines)
  • Knowledge of MedDRA terminology and its application
  • Experience in the preparation and authoring of pre- and post- aggregate safety reports, RMPs, and RSI
  • Thorough understanding of the drug development process and context applicable to safety surveillance activities
  • Excellent verbal and written communication skills as well as presentation and team-interaction skills are necessary
  • Strong time management, prioritization, organizational and multitasking skills are required
  • Excellent interpersonal, team management and leadership skills
  • Proficiency in Microsoft Office and experience with safety databases; Argus experience is a plus
  • Education:          
  • Degree in Medicine, Pharmacy or Nursing (MD, DO, PharmD, PhD)
  • Pharmaceutical industry background and proven competence in PV preferred
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