On behalf of our client, a fast-growing pharmaceutical company in Europe, we are looking for a successful candidate to fill the position of the REGULATORY AFFAIRS AND PHARMACOVIGILANCE MANAGER, with an opportunity for fast growing and promotion.
- Medicine or Pharmacological degree is a must;
- Experience in Regulatory Affairs (minimum 3 years);
- Experience in Pharmacovigilance (minimum 1 year);
- Experience and knowledge in other relevant areas (such as research, quality control, manufacture or quality assurance) within the pharmaceutical industry and relevant aspects of the law will be a plus;
- Upper-Intermediate level of English is a must;
- Excellent organizing skills, good oral communication and writing skills, reading comprehension skills, attention to details, critical and analytical thinking;
- Collaborative, tactical, diplomatic.
- Planning and managing of medicine products/food supplements registration process according to the company business plan;
- Planning and managing local regulatory submissions in compliance with local regulatory Requirements;
- Developing Normative documents, Patient Information Leaflets, and product packaging Artworks;
- Communication with Regulatory Authorities, outside organizations, and contractors regarding registration of medicine products and food supplements;
- Preparing responses to the Ukrainian Regulatory Authorities requests;
- Preparation of contracts/agreements associated with registration processes of medicine products/food supplements;
- Obtaining import permits (license) for reference standards and samples;
- Foreseeing changes in regulatory environments, alerting the management about upcoming changes & changing the product development, regulatory & manufacturing strategies accordingly;
- Ensure regulatory support to GMP inspections; assistance in preparing CAPA plan;
- Track product events, complaints and recalls;
- Coordination of Regulatory Department activities and train staff in regulatory policies or procedures;
- Interactions with cross-functional teams (Logistic Department, Marketing Department, Quality Department, etc.).
- Maintenance of the Global Pharmacovigilance system;
- Management of ADRs (collecting, reporting, obtaining follow up, detection of duplicates);
- Submission of PV documents (PSUR and other) to Competent Authorities;
- Local literature search, sending reports to the HQ of the performed local literature search;
- Preparation and update of local pharmacovigilance SOPs and ensuring implementation of SOPs concerning global PV System of company and local PV processes;
- Continuous pharmacovigilance education and training including training other company staff (medical representatives etc.);
- Act as a single contact point for the Competent Authorities;
- Communication and sharing information with the PV Unit of the HQ, including reporting any changes in the PV legislation.
- Competitive salary;
- The official employment in accordance with the Labour Code of Ukraine;
- Career prospects;
- Professional development.
Contact Anastasiya Maximenko for details: +380 (97) 953-68-14, AMaximenko@upharma-c.com