BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
- Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving BioMarin 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 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
- 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.
- 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
Degree in Medicine, Pharmacy or Nursing (MD, DO, PharmD, PhD)
Pharmaceutical industry background and proven competence in PV preferred.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.