Pharmacovigilance Associate II

Pharmacovigilance Associate

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. The mission of the Pharmacovigilance (PV) function is to lead multidisciplinary efforts to actively and effectively monitor the safety of Pharmacovigilance products throughout their lifecycle, rapidly act on validated new safety information, and ensure a state of global PV compliance.

Summary The Associate is responsible for case initiation, data entry for non-expedited ICSRs, quality review and submissions. The Associate II position requires a solid foundational ability to communicate well and work collaboratively on a team and a good level of competence to act proactively and effectively respond to workflow challenges. An aptitude for effective decision-making and problem-solving is also required.

Key Responsibilities:

• Case Initiation and Processing
• Monitor the BPV Inbox and Argus safety database for receipt of safety information routinely throughout the business day
• Promptly review all relevant incoming items, using source document(s) to assess whether the case is valid and checking for duplicate cases; initiate all initial reports into the safety database per appropriate work instruction
• Perform data entry for all non-serious ICSRs and all serious, non-expedited ICSRs (serious ICSRs with no regulatory submissions), ensuring timelines are met
• Ensure all pending actions are completed and earliest received cases are prioritized; leverage email classification systems to categorize and prioritize incoming cases
• Process follow up cases / previously reported events
• Confirm receipt of case information by forwarding confirmation of safety reports received and providing Pharmacovigilance case numbers to appropriate partners
• Perform quality review. Review the source documentation to identify data which should be entered into the safety database, including review of all applicable data entered to assure accuracy
• Support submissions, including submitting reports to regulatory authorities and business partners and supporting the development of the cover letter and 1571 form for IND safety reports. Resolve submission problems as necessary
• Conduct reconciliation of vendor / partners safety database with Pharmacovigilance safety database

Education & Experience:

• BA/BS degree in health or life sciences. Relevant experience in lieu of education accepted
• 3+ years of pharmacovigilance experience

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.