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Medical Director, Medical Evaluation & Risk Management

BioMarin Pharmaceutical Inc.

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Location: San Rafael or Brisbane, CA Posted Date: 4/12/2013 Position Type: Full time Job Code: 12-0275 Required Education: High school or equivalent

Description

BioMarin Pharmaceutical Inc.
At BioMarin, we recognize and value each employee’s contribution toward reaching our corporate mission—to develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them.

Today, with four products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us.

EEO/M/F/D/V
To apply: Visit www.BMRN.com Job Code 12-0275

Develop and assist in leading cross-functional signal detection/safety surveillance, clinical risk management, core safety information, and aggregate report best practices for BioMarin products.

RESPONSIBILITIES:
• 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
• 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
• Lead 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.

To apply: Visit www.BMRN.com Job Code 12-0275

Requirements

EDUCATION:
Degree in Medicine, Pharmacy or Nursing
Pharmaceutical industry background and proven competence in PV preferred.

EXPERIENCE:
• Minimum of 5 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
• Strong 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

To apply: Visit www.BMRN.com Job Code 12-0275
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