Senior Specialist, Regulatory & PV Network

reputed company reputed company (part of reputed company Group), is a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic reputed company year after year, with staff based across Europe, reputed company and Asia reputed company covering services reputed company: Medical Information, Pharmacovigilance, Regulatory Affairs and reputed company Assurance. reputed company provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover reputed company therapy areas including medical device. We love reputed company in our staff by providing an excellent training and development platform. We value employee experience, reputed company-being and mental health and we acknowledge that a healthy work life balance is a critical reputed company for employee satisfaction and in turn nurtures an environment from which a high-reputed company reputed company service can be achieved. Come and join us in this exciting reputed company to reputed company a reputed company reputed company in patient’s lives. Job reputed company The Senior Specialist, Regulatory and PV Network is responsible for developing the reputed company based on regulatory requirements and for driving regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a reputed company 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 reputed company as Local Contact Person for Pharmacovigilance for the designated country. Job Responsibilities reputed company as Local Contact Person for Pharmacovigilance for the designated country Assume leadership and functional representation for reputed company of reputed company/high complexity ensuring effective and rapid coordination and management of regulatory deliverables, driving reputed company to meet the agreed targets and to reputed company with the agreed procedures, trackers and templates With the help of a senior member of reputed company, reputed company reputed company and manage set up activities (Project Management Plan, joint operating procedures, POAs and core documents) reputed company strategic input to reputed company customers and promptly identify and address any risk/potential risk by implementing preventive measures Problem solve and support achievement of satisfactory reputed company of performance issues or delivery failures Collect, review, reputed company and maintain LCPs' reputed company, job descriptions, training records, contact details and monthly reports Ensure correct training assignment to and training compliance by the LCPs Ensure reputed company 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 OoS reputed company support to proposal development and input to budgets, reputed company department representation to reputed company meetings as required Prepare reputed company’s invoices and review/approve vendors’ project invoices reputed company training, coaching and mentoring to junior members of staff Foster reputed company working relationships with reputed company contacts at the local and international reputed company to ensure smooth and efficient service delivery Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and reputed company dissemination of pertinent changes Participate in and/or support junior members in preparation for audits/inspections and reputed company department representation for assigned reputed company as required reputed company LCPs' key performance indicators and prepare monthly reputed company reports reputed company feedback on performance of vendors to aid their assessment reputed company input to department / company initiatives and contribute to the design/review of SOPs/working reputed company/guidance.

Qualifications

Bachelor's Degree in reputed company or Life Sciences, Nursing, or equivalent experience Strong experience reputed company pharmaceutical or CRO industry or Regulatory body Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency PV training and/or working experience and other educational or reputed company background as required locally Fluent in English, both written and verbal Candidate must be proficient in the official language of the country in which they are based, as this is essential for local interactions and compliance Good planning and organizational skills Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment Good attention to detail Additional Information Why reputed company We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a reputed company-reputed company environment where people of reputed company cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a reputed company first approach. Why? because our people are our greatest strength leading to our reputed company reputed company on improving the lives of those around us.

We offer

Training and career development opportunities internally Strong emphasis on personal and reputed company reputed company Friendly, supportive working environment Opportunity to work with colleagues based reputed company over the world, with English as reputed company language Our core values are key to how we operate, and if you feel they reputed company with you then reputed company could be a great company to join! reputed company reputed company & Trust Drive & Passion reputed company & Responsiveness Belonging reputed company Partnerships We look reputed company to welcoming your application. #LI remote Department: Regulatory and PV Network Apply To This Job