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Responsibilities
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 Specialist, Regulatory and PV Network is responsible for developing the strategy based on regulatory requirements and for driving regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies.The Senior Specialist will also act as Local Contact Person for Pharmacovigilance for the designated country.Job ResponsibilitiesAct as Local Contact Person for Pharmacovigilance for the designated countryAssume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templatesWith the help of a senior member of the team, develop strategy and manage set up activities (Project Management Plan, joint operating procedures, POAs and core documents)Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measuresProblem solve and support achievement of satisfactory resolution of performance issues or delivery failuresCollect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reportsEnsure correct training assignment to and training compliance by the LCPsEnsure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoSProvide support to proposal development and input to budgets, provide department representation to BD meetings as requiredPrepare client’s invoices and review/approve vendors’ project invoicesProvide training, coaching and mentoring to junior members of staffFoster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service deliveryStay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changesParticipate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as requiredTrack LCPs' key performance indicators and prepare monthly summary reportsProvide feedback on performance of vendors to aid their assessmentProvide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.QualificationsBachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experienceStrong experience within pharmaceutical or CRO industry or Regulatory bodyGood knowledge of ICH GCP and/or GVP and national regulations for territories of competencyPV training and/or working experience and other educational or professional background as required locallyFluent in English, both written and verbalCandidate must be proficient in the official language of the country in which they are based, as this is essential for local interactions and complianceGood planning and organizational skillsStrong interpersonal skills in a fast-paced, deadline oriented, and changing environmentGood attention to detailAdditional InformationWhen 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.
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