Bachelors degree in life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related field, or equivalent experience required.
Familiarity with CSV, categorization, risk assessment and instrumentation qualification. Candidates with an OSD/Injectable/API background can be considered.
Bachelors degree in Life Sciences, Pharmacy, Medicine. experience in Pharmacovigilance PV within the pharmaceutical or biotech industry. Proven hands-on experience in PV operations e.g., case processing, signal detection, risk management, safety surveillance
Lead pipeline strategy and introduce new products to the in-house pipeline through ROI and feasibility checks. Scout unmet needs, new therapies, dosage forms and spaces to enter, with break-even estimations
Record and review adverse reactions in the safety database for post marketing and clinical trial reports in accordance with applicable regulatory standards, with high accuracy and quality.
Operation, calibration, and maintenance of GC, HPLC, and analytical instruments. Analysis of raw materials, finished products, cleaning samples, and stability samples.
Formulation analytical method development using LCMS/MS, preferably using Waters make. Formulation analytical method development using HPLC/GC/IC/Potentiometry.