Pharmacovigilance Business Process Lead
Who We Are
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
Manager to Senior Manager, BioMarin Business Process Development Lead
City: Brisbane or San Rafael or Flexible
The Biomarin Pharmacovigilance Process Development Lead (BPV-PDL) is responsible for oversight and maintenance of safety science processes in accordance with global PV regulations.
The BPV-PDL will lead activities that span the safety science contributions to the BioMarin PV system through the application of best-in-class global PV standards, quality, and compliance with PV policies, best practices, processes, and other resources. Over the entire lifecycle of a process the BPV-PDL orchestrates and/or contributes to process development, process implementation, continuous improvement, compliance management, inspections, audits, CAPAs, and cross-functional collaboration.
The activities and responsibilities of the BPV-PDL will enable the evaluation of high-quality safety data for the ongoing evaluation of the benefit/risk profile of development and marketed products. The BPV-PDL drives business process change to adapt to changing regulatory requirements, and enables inspection readiness at all times, resulting in quality and compliance as competitive advantages.
RESPONSIBILITIES1. Direction and oversight of Safety Science Processes
- Accountable process owner for the allocated GCP/GVP process.
- Define the content of the allocated global process; review and approve requests for global process changes, including process improvements.
- Identify and assess the impact of new or changing regulations to the allocated global process.
- Align with system application administrators on associated system functionalities that enable the global process.
- Regularly communicate and engage with stakeholders for allocated global process.
- Ensuring effective BPV leadership of cross-functional process development teams (eg. aRMM process).
2. Procedural documentation
- Draft and project manage the safety science related content of global procedural documents
- Support any document assessment needed for the allocated global process
- Initiate revisions to global procedural documents and track to finalization as needed
- Manage process deviations for safety science
- Align with the primary Quality Assurance organization to determine the need for new or amended global procedures
- Approve the withdrawal of a global procedural document where appropriate
- Define, review, and approve the training materials in consultation with Safety Science leadership
- Maintain oversight of the safety science training audience and review curriculum to ensure appropriateness
- Make recommendations on improvements to training materials
- Take action on an ongoing basis to maintain inspection readiness for the allocated global process in collaboration with cross-functional stakeholders
- Management of inspection related activities for safety science
- Periodically review trends from deviations to the allocated global process
- Assess and decide upon required actions based on compliance trends identified by data derived by audits inspections, etc.
- Take ownership and oversight of CAPAs associated with the allocated global process
- Define measures and metrics
- Review measures and identify any relevant trends
- Propose remediation actions
- Escalate key issues to management, governing bodies, etc.
- 4-year College Degree (BA, BS).
- Pharmaceutical industry background and proven competence in PV preferred. Applicants with a background in quality, compliance, process development, process management preferred.
- Minimum of 3 years of Pharmacovigilance experience; with previous signal detection/safety surveillance, case processing, compliance, process development, quality, and international experience preferred.
- Prior experience in writing, managing, and updating controlled documentation
- Prior experience managing pharmacovigilance audits and inspections
- 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 reference safety information (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
- Able to lead complex process improvement projects
- Demonstrated ability to proactively predict and resolve complex problems, think strategically and tactically, generate solutions to complex problems and build consensus across global organization.
- Proficiency in Microsoft Office and experience with safety databases; Argus experience is a plus.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.