Senior Manager, Regulatory and PV Delivery

- Full-time
- Department: Regulatory and PV Network

Medicine moves forward here. So willyou.

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-solversand experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America,Asiaand Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another andgood ideasare heard wherever they come from.

If you want a role with real purpose, globalreachand 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 providingfranchise liaison between Ergomed Group and client on a multiple projects’program and actively assist senior management in securing recent business by participating to BDMs andcontributing to proposals/budgets. They also provide strategic regulatory guidance, training, coachingand 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 highcomplexity ensuring effective and rapid coordination and management and execution ofregulatory tasks, driving the team to meet the agreed targets and to comply with the agreedprocedures, trackers and templates.
- Provide strategic input to internal and external customers and promptly identify and addressany risk/potential risk by implementing preventive measures. Problem solve and ensuresatisfactory 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 localregulations/guidance.
- Assist in securing new business or repeated business by participating to BDMs, developingand reviewing regulatory sections of proposals, regulatory costing and budgets.
- Foster professional working relationships with internal and external contacts at the local andinternational levels to ensure smooth and efficient service delivery
- Provide training, coaching and mentoring to junior members, may be required to line
- manage members of staff.
- Support client qualification activities.



Ensure audit readiness and assign team members toparticipate as departmental representatives for audits/inspections and provide responses toany findings/follow up questions.
- Drive department / company initiatives, act as a change champion and successfully manageimplementation of the changes (communication, timing and implementation plan)

Minimum 5 years within pharmaceutical or CRO industry orRegulatory body, of which at least 3 years in a leading/projectmanagement role
Proven ability to successfully manage global projects

Hands-on experience with post-marketing regulatory activities and lifecycle management highly recommended

Why PrimeVigilance

When you joinErgomedGroup, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world.You’lljoin 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 theoutcome, becausesomeone is waitingonit.

Agility and responsiveness:we movequickly, becausepatients 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.

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📌 Senior Manager, Regulatory and PV Delivery (Melbourne)
🏢 Ergomed Group
📍 Melbourne