Manager, Regulatory and PV Delivery

Medicine moves forward here. So willyou.

At Prime Vigilance, 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.

Job Description

The Manager, Regulatory and PV Delivery is responsible for developing the strategy based on regulatoryrequirements and for driving regulatory and PV deliverables based on an established PV and regulatoryplan.

They actively assist senior management in securing new business by participating to BDMs and
contributing 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 expert advice to Clients addressing complex queries and changes in localregulations/guidance.
• Ensure all team members assigned to the project for departmental deliverables are aware ofthe tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptlyidentify and elevate any Oo S.
• Assist in securing new business or repeated business by participating to BDMs, developingand reviewing regulatory sections of proposals, regulatory costing and budgets.
• Prepare client’s invoices and review/approve vendor’s project invoices
• Provide training, coaching and mentoring to junior 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.

• Prepare and/or contribute to the Regulatory Newsletter and update regulatory database
  when new information is available.
• Ensure collection, QC review and timely dissemination of all regulatory intelligence related to
  departmental deliverables.

Support interpretation and impact analysis on legislation.

• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
• Drive department / company initiatives, act as a change champion and successfully manageimplementation of the changes (communication, timing and implementation plan)

Qualifications

• Minimum 3 years within pharmaceutical or CRO industry or Regulatory body, of which at least 3 years in a leading/projectmanagement role.
• Proven ability to successfully manage global projects.
• Expert knowledge of ICH GCP and/or GVP and most relevantlegislation/ local requirements for territories of competency.
• Additional Information
• Why Prime Vigilance

When you join Ergomed Group, 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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