Description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our WWRD engine 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 genetic diseases.

 This is a REMOTE CONTRACT ROLE : (CW) Medical Director 

SUMMARY DESCRIPTION 

(CW) Medical Director, Pharmacovigilance: The Medical Director of Pharmacovigilance (PV) is responsible for strategic leadership and medical oversight of BioMarin PV (BPV) activities in collaboration with the EU Qualified Person for PV (EU QPPV), BPV colleagues, and applicable cross-functional specialists, with special focus on identification, evaluation and management of safety  risks throughout BioMarin products lifecycle. 

PRIMARY RESPONSIBILITIES 
• 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. 
• Contribute to the preparation of departmental policies and SOPs that address the  processing, analysis and reporting of safety information in accordance with evolving  best practices. 
• Assist in follow-up of important ICSRs to ensure relevant information is sought. 
• Assist with literature review to identify adverse drug reactions as needed. 
• Collaborate with Clinical Science, Medical Affairs, PV colleagues and applicable  functional specialists to identify, evaluate and manage safety signals. 
• Participate in the development of safety surveillance and risk management plans for drug development programs.  
• Contribute to the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report). 
• Participate in the preparation and provision of PV training as needed. 
• Serve as medical safety expert and liaise with clinical study/project teams, Clinical  Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research  

Organizations (CROs), Data Monitoring Committees and other entities as needed. 
• Provide medical advice and inform Global Head of PV and EU QPPV of critical  issues, as appropriate. 
• Oversee analysis of similar events for applicable interventional study safety reports. 
• Participate in the preparation and revision of company core safety information and  associated product labeling. 
• Collaborate with Medical Directors in both Clinical Development and Medical  (Commercial) Affairs to provide expertise in both US and ex-US post-marketing  safety surveillance requirements (e.g., registries). 
• Review and advise on safety/medical information in advertising and promotional  materials as needed. 
• Help prepare and review safety section(s) of investigator brochures, protocols,  informed consent forms, clinical study reports, NDA/BLA/CTD submissions and other  
• Interface with business partners as needed in accordance with applicable safety Data Exchange Agreements. 
• Provide support for internal and external PV audits as needed. 
• Other duties as assigned. 

SCOPE 
This position is responsible for ensuring thorough medical and clinical review in support of pharmacovigilance activities. There may be some additional costs  incurred
by this position through periodic required travel. 

EDUCATION 
 
• Medical degree (e.g., MD, DO) with the appropriate clinical and pharmacovigilance experience required. 

EXPERIENCE 
 • Minimum 5 years’ experience in PV with specific drug safety operational experience. 
• Prior experience in pharmaceutical industry with international experience preferred.  
• Excellent medical knowledge with the ability to interpret, synthesize and  communicate complex medical/pharmaceutical information and safety data to both  healthcare professionals (HCPs) and non-HCPs. 
• Experience reviewing cumulative safety data. 
• Strong working knowledge of US and ex-US PV requirements (e.g., US Code of  Federal regulations; European Union Volume 9A for post-marketing PV and Volume  10 clinical trials directive; and ICH Guidelines). 
• Experience with pre- and post-marketing ICSR processing and aggregate safety  reporting. 
• Knowledge of MedDRA terminology and its application. 
• Experience in the preparation of PSURs, Pharmacovigilance Plans, Risk  Management Plans, and Reference Safety Information. 
• Experience in safety issue/signal management. 
• Thorough understanding of the drug development process and context applicable to  safety surveillance. 
• Managerial experience in a Drug Safety department desirable. 
• Excellent verbal and written communication skills, including formal presentations. 
• Sound organizational skills with the ability to prioritize tasks. 
• Excellent interpersonal, team management and leadership skills. 
• Proficiency in Word, Excel, and safety databases. 

WORK ENVIRONMENT / PHYSICAL DEMANDS 
 Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals;  risk of electrical shock and vibration. The noise level in the work environment is usually moderate. 
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with  hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.  The
employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus. 

EQUIPMENT 
Computer work, utilizing common software programs and the pharmacovigilant

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.