Senior Manager, Regulatory and PV Delivery
- Role
- Project Management
- Experience
- Senior
- Employment
- Full-time
Open to AU only. Set where you work from to check your eligibility.
No BS summary
Senior regulatory/PV delivery manager with 5+ years in pharmaceutical, CRO or regulatory body work, including 3+ years leading projects. Needs global project management experience, expert ICH GCP and/or GVP knowledge, and post-marketing regulatory/lifecycle management experience is highly recommended. Role is based in Melbourne, Australia.
Required skills
Medicine moves forward here. So will you.
At PrimeVigilance, patient safety is not one part of the job. It is why we exist.
We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.
That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from.
If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.
The Senior Manager, Regulatory and PV Delivery is responsible for providing franchise liaison between Ergomed Group and client on a multiple projects’ program and actively assist senior management in securing new business by participating to BDMs and contributing to proposals/budgets. They also provide strategic regulatory guidance, training, coaching and mentoring to junior members; may be required to line manage members of staff.
Main responsibilities:
- Assume leadership and functional representation for projects and/or deliverables of high complexity ensuring effective and rapid coordination and management and execution of regulatory tasks, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
- Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures. Problem solve and ensure satisfactory resolution of performance issues or delivery failures.
- Provide franchise liaison between Ergomed Group and client on a multiple projects’ program
- Provide expert advice to Clients addressing complex queries and changes in local regulations/guidance.
- Assist in securing new business or repeated business by participating to BDMs, developing and reviewing regulatory sections of proposals, regulatory costing and budgets.
- Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
- Provide training, coaching and mentoring to junior members of staff, may be required to line
- manage members of staff.
- Support client qualification activities. Ensure audit readiness and assign team members to participate as departmental representatives for audits/inspections and provide responses to any findings/follow up questions.
- Drive department / company initiatives, act as a change champion and successfully manage implementation of the changes (communication, timing and implementation plan)
Minimum 5 years within pharmaceutical or CRO industry or Regulatory body, of which at least 3 years in a leading/project management role Proven ability to successfully manage global projects Expert knowledge of ICH GCP and/or GVP and most relevant legislation/ local requirements for territories of competency.
Hands-on experience with post-marketing regulatory activities and lifecycle management highly recommended
Why PrimeVigilance
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
- Quality: we hold ourselves to the standard patients deserve.
- Integrity and trust: we do the right thing, especially when it is hard.
- Drive and passion: we care about the outcome, because someone is waiting on it.
- Agility and responsiveness: we move quickly, because patients cannot wait.
- Belonging: everyone is welcome, and every voice counts.
- Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.
What you'll do
- Assume leadership and functional representation for projects and/or deliverables of high complexity ensuring effective and rapid coordination and management and execution of regulatory tasks, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
- Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures.
- Problem solve and ensure satisfactory resolution of performance issues or delivery failures.
- Provide franchise liaison between Ergomed Group and client on a multiple projects’ program
- Provide expert advice to Clients addressing complex queries and changes in local regulations/guidance.
- Assist in securing new business or repeated business by participating to BDMs, developing and reviewing regulatory sections of proposals, regulatory costing and budgets.
- Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
- Provide training, coaching and mentoring to junior members of staff, may be required to line manage members of staff.
- Support client qualification activities.
- Ensure audit readiness and assign team members to participate as departmental representatives for audits/inspections and provide responses to any findings/follow up questions.
- Drive department / company initiatives, act as a change champion and successfully manage implementation of the changes (communication, timing and implementation plan)
What they require
- Minimum 5 years within pharmaceutical or CRO industry or Regulatory body, of which at least 3 years in a leading/project management role
- Proven ability to successfully manage global projects
- Expert knowledge of ICH GCP and/or GVP and most relevant legislation/ local requirements for territories of competency.
- Hands-on experience with post-marketing regulatory activities and lifecycle management highly recommended
Benefits
- Medicine moves forward here. So will you.
- If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here.
- When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world.
- You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
- Quality: we hold ourselves to the standard patients deserve.
- Integrity and trust: we do the right thing, especially when it is hard.
- Drive and passion: we care about the outcome, because someone is waiting on it.
- Agility and responsiveness: we move quickly, because patients cannot wait.
- Belonging: everyone is welcome, and every voice counts.
- Collaborative partnerships: we go further by going together.
PrimeVigilance is a global pharmacovigilance specialist helping clients navigate complex regulations and patient safety from early development through post-marketing surveillance.
What people say about this company
2.5/ 5