Post Marketing, Medical Coding and Device Safety PV Scientists Lead

CSL Plasma; City of Melbourne; On-site; AUD 100,000 - 130,000; Full time

Job summary

A leading biotherapeutics company is seeking a PV Scientist to manage lifecycle safety and risk management activities. This role requires a PhD or equivalent in a relevant field, plus 8+ years of experience in pharma/biotech, with strong skills in pharmacovigilance and communication. The successful candidate will work collaboratively on post-marketing products and contribute to signal detection efforts within a dynamic team. Based in Melbourne, this position also offers strategic impact in a global health context.

Qualifications

• 8+ years of experience in pharma/biotech, with at least 3 years in Pharmacovigilance.
• Strong knowledge of ICH, GCP, GVP regulatory requirements.
• Experience with signal detection and management.

Responsibilities

• Ensure PV standards and processes are implemented.
• Support post-marketing phase products and ongoing clinical development.
• Collaborate with various stakeholders for signal detection.

Skills

Pharmacovigilance

Communication skills

Analytical skills

Problem-solving

Project management

Education

PhD, PharmD, or Masters in Medicine, Pharmacy, Epidemiology or related field

Job description

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.

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 based 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.

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 https://www.csl.com/.

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.