Associate Medical Director in Brisbane, CA at APEX Systems

Date Posted: 10/19/2019

Job Snapshot

  • Employee Type:
  • Location:
    Brisbane, CA
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Job #:  1013175
Apex Systems is looking for an Associate Medical Director for one of our large biotech clients in Brisbane, CA. If you are interested in applying for this position, please reach out to recruiter Ashlyn Hardman at
Duties: 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 BioMarin 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 Other duties as assigned.

Skills: 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.

Hours Per Week: 40.00

Hours Per Day: 8.00
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.