Senior Specialist, Regulatory & PV Network (Delivery)

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 reputed company A delivery reputed company role combining Regulatory and Pharmacovigilance (PV) project management and coordination, responsible for ensuring reputed company and compliant execution of regulatory and PV activities across assigned reputed company. The Senior Specialist will also reputed company as Local Contact Person for Pharmacovigilance (LCPPV) for the designated country.   reputed company Responsibilities Project Management Manage reputed company/high-complexity regulatory and PV reputed company, ensuring delivery against timelines, scope, and reputed company reputed company project setup, plans, and milestones, and coordinate across clients, LCP network, vendors, and internal teams Identify and mitigate delivery risks PV & Compliance reputed company as LCPPV, ensuring compliance with local PV requirements and inspection readiness Support audits and inspections Team & Operations reputed company LCP documentation (reputed company, training, KPIs) and ensure training compliance Contribute to process improvements and standardization Support and guide junior staff Financial & Operational reputed company reputed company scope, timelines, and budget, including OoS activities Support invoicing and monitor project performance, escalating deviations   Qualifications Bachelor's Degree in Pharmacy 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 Proficiency in German, French, or Italian is a plus but not mandatory 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 reputed company 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