Profile: Dnyaneshwar or Dnyan (known as Dan in industry circle) is a qualified physician of Indian origin, with a total experience of > 17 years. He has worked across almost all pharmacovigilance business models (both developmental and post-marketing) since then. He worked as an EU-QPPV, is a qualified GvP auditor. Has successfully (faced and) closed major regulatory authority inspections incl. EMA, MHRA and FDA. Over 4 years of experience in clinical practice (primary- tertiary healthcare centers). Over 13 years of exclusive experience in end-to-end pharmacovigilance activities; across all business models (academia, vendors, industry-post marketing and developmental / generics / innovator). Master of pharma business administration: Basic knowledge of complete pharmaceutical value chain including research, development and galenics, production and quality, market access and health economics (HEOR), marketing and sales, medical / regulatory affairs and pharmacovigilance, and pharma business planning. Working knowledge of ICH-Good Clinical Practices, FDA and EMA investigational and post marketing regulatory guidelines. Experience in medical review /approval of ICSRs, writing aggregate safety reports, RMP and signal evaluation reports, quality Management (PV-QA) and people management. Knowledge of Good Pharmacovigilance Practices modules, ICH and CIOMS guidelines. Effective communication, organization and time management skills. Ability to work independently under tight time constraints. Good interpersonal skills and the ability to operate effectively in an international environment. Computer Literacy. Languages Known: can speak, read, write Hindi, English, Marathi, Dutch and German. Based in Germany.