Local Pharmacovigilance Specialist
virtual vocationsDenver, CO
Local Pharmacovigilance Specialist
L5
virtual vocationsDenver, COtoday
Industries
Pharmaceutical Preparation ManufacturingBiological Product ManufacturingMedicinal and Botanical ManufacturingActing as the primary local RA & PV representative, the full-time Local Pharmacovigilance Specialist will ensure compliance with national pharmacovigilance and regulatory requirements in Hungary, executing PV and RA activities while supporting the Marketing Authorisation Holder throughout the product lifecycle.
Key responsibilities:
Communicate promptly and effectively with the Marketing Authorisation Holder and local regulatory authorities
Provide local regulatory intelligence and expert advice while managing risk minimization measures related to safety issues
Collect and report locally suspected adverse drug reactions and maintain accurate local records and documentation
Required qualifications:
Bachelor's Degree in Life Sciences, Chemistry, Nursing, or equivalent professional experience
At least 3 years of pharmacovigilance or safety-related experience in a pharmaceutical, CRO, or regulatory environment
Good understanding of ICH GVP and local pharmacovigilance requirements
Experience in case handling or local PV activities is preferred
Proficiency in English; additional language knowledge is advantageous
Apply now (opens in a new tab)
Level
SeniorL5
Location
Denver, CO
Occupation
Regulatory Affairs Specialists
Industry
Pharmaceutical Preparation Manufacturing
Posted
today
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