Mag. Nikola Kocev

Follow pharmacovigilance legislation in all countries of interest; Developing of SOPs for pharmacovigilance activities; Adverse drug reaction (ADR) reports processing (collection, coding, evaluation, causality assessment, reporting, signal detection); Production of aggregate reports (PSURs). Creation, testing and maintenance of Business Continuity Plan.

Regulatory Officer: Product registration and life-cycle management. Ensuring that product on the market is aligned with company’s and country regulatory requirements. Named Safety Contact: Management of pharmacovigilance for marketed products and products in clinical trials, including Pharma, Vaccines and Consumer Healthcare. Quality representative: Responsible for the ensuring a robust, sustainable and effective Quality Management System through monitoring and reviewing of the compliance status.

Regulatory Affairs; R&D of new products; Registration of new products; Quality control of intermediate products, Pharmacovigilance.

The specific competencies include theoretical knowledge and practical use of the knowledge in development of medicines from potential pharmaceutical dosage form/therapeutic system, from formulation to registration.