Senior Specialist, Regulatory & PV Network

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.Bachelor'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 complianceProficiency in German, French, or Italian is a plus but not mandatoryGood planning and organizational skillsStrong interpersonal skills in a fast-paced, deadline oriented, and changing environmentGood attention to detailWhy PrimeVigilanceWe prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. We offer: Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships We look forward to welcoming your application. #LI remotePrimeVigilance (part of Ergomed Group), is a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to our small to large pharmaceutic