Post Marketing, Medical Coding and Device Safety PV Scientists Lead
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
The Post Marketing, Medical Coding and Device Safety PV Scientists Lead is the line manager of PV Scientists that primarily serve as key contributors to lifecycle safety and risk management activities for CSL products, specifically for products with existing open marketing authorizations, providing strategic input into the process and ensuring scientific analyses are conducted with rigor, with the goal of proactive safety management.
Your responsibilities
- Ensure implementation of GVP compliant PV standards, processes by the Pharmacovigilance Scientists, Device expert, and Medical coding expert under their management and conducts cross-functional collaboration with relevant individuals within PV as well as with key stakeholders
- PVS support for products in the post-marketing phase, as well as those products with ongoing clinical development as required
- Collaboration with Signal Management/Governance/Literature and Aggregate Reports/Risk Management Heads to support the work of PVS within the team, specifically in the contribution to signal detection and assessment activities through the full governance process, literature screening, and key contributions to aggregate reports, risk management plans, and other PVS-assigned responsibilities
- Utilization of managed service partners, ensuring on-time delivery of high-quality outputs assigned with implementation of meaningful KPI measures and regular reporting to senior management will be required
- Creating and implementing a vision which incorporates new technologies and innovative approaches will be essential to lead the team, while ensuring consistent support of the product-responsible GSLs.
Your Experience:
- PhD, PharmD, Masters, or equivalent in Medicine, Pharmacy, Epidemiology or related field
- 8+ years progressive experience in pharma/biotech with at least 3 years direct experience as a Pharmacovigilance Scientist and/or in combination other related PV science function
- Strong knowledge of ICH, GCP, GVP regulatory requirements as well as clinical development with advanced understanding of Pharmacovigilance, specifically signal detection and management, as well as clinical trial safety
- Strategic thinking/problem-solving skills with strong communication/interpersonal skills, with the ability to analyze, synthesize, interpret, and present scientific data
- Ability to manage multiple projects and timelines in a cross-functional environment
- Experience in working with managed service providers
- Experience across multiple therapeutic areas is strongly preferred
- Some international travel will be expected
This role can be base in Melbourne, Australia - Zurich, Switzerland or King of Prussia.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
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CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Perks and Benefits
Health and Wellness
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-Term Disability
- Long-Term Disability
- FSA
- HSA
- Mental Health Benefits
Parental Benefits
- Adoption Leave
- Birth Parent or Maternity Leave
- Non-Birth Parent or Paternity Leave
- Fertility Benefits
- Adoption Assistance Program
- Family Support Resources
Work Flexibility
Office Life and Perks
- Commuter Benefits Program
Vacation and Time Off
- Paid Vacation
- Paid Holidays
- Personal/Sick Days
- Leave of Absence
- Volunteer Time Off
Financial and Retirement
- 401(K) With Company Matching
- Stock Purchase Program
- Financial Counseling
Professional Development
- Tuition Reimbursement
Diversity and Inclusion