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Regulatory Affairs and Pharmacovigilance Specialist (m/f)
Lugera Talent Solutions (ex Adecco) is leader in providing HR services.
Our client is Organon, a Women’s Health Company that believes in a better and healthier every day
for every woman. They are a passionate, global community of thousands dedicated to redefining the
future of women’s health. Their mission is to deliver impactful medicines and solutions for a healthier every day.
We are seeking a real, passionate team player, a curious innovator, and a forward thinker empowered by the idea of shaping their career. If you're ready to bring your fire to embrace change and seize opportunities, we invite you to join the team as:
Regulatory Affairs and Pharmacovigilance Specialist (m/f)
Location: Zagreb
ABOUT THE ROLE:
The Specialist is responsible for all PV and RA submission requirements and PV activities for their assigned product portfolio as applicable. The Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and drug safety oversight.The Specialist is also responsible for other activities (as delegated/assigned by their manager) which may include but are not limited to: a review of local PV and RA agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, authoring/reviewing SOPs, training, communication of safety issues, developing product registration plans and strategies.
WHAT YOU'LL DO:
- Execution of country RA and PV processes and activities in accordance with local and company Procedures and Policies and in accordance with the country legislation
- Timely preparation and submission of new Marketing Authorization Applications to local Health Authorities, life-cycle management of authorized products and post-approval activities, including but not limited to artwork management
- Intake management of cases received from the designated point of contact, Vendors, and Business Partners for Individual case safety reports (ICSRs), product quality complaints (PQCs) and serialization alerts including tracking and translation to English and forwarding of information to the Data Management Center
- Daily pharmacovigilance activities including but not limited to adverse events case management, case intake and follow-up activities in accordance with Global Pharmacovigilance procedures and country regulations
- Filing, storage and archiving of safety-related and regulatory data and documentation in accordance with department and company policies and local requirements
- Support in local RA and PV audits and inspections including readiness activities, support with audits of contractual partners/vendors as necessary and support with other audits/inspections activities including the development of CAPAs in response to findings/observations
- Support drug shortage management and regulatory requirements for reporting, including cross-functional collaboration
WHAT YOU’LL NEED:
- Health, life science, or medical science degree
- Minimum of 1 year of industry experience in pharmacovigilance and/or regulatory affairs
- Ability to work in partnership with others (internally and externally) to accomplish quality goals
- Good communication skills to convey and receive information in English and the local language
- Problem-solving skills
- Good skills in the ability to organize work efforts, prioritize tasks and utilize appropriate resources to support PV and RA activities in accordance with timelines and appropriate regulations
- Strong skills to utilize knowledge, networks, and data to make rapid and appropriate decisions with management oversight and to determine when escalation of issues is necessary
- Excellent language skills in English (written and spoken) while proficient in the Croatian language
Please be advised that the contract duration is for a definite period of 14 months.
If you are a Regulatory/PV enthusiastic, dynamic, eager to develop, wanting to have an influence on what is happening and open for challenges, please send us your CV in English via application link and join this amazing team.
Note: Please mind that only the candidates selected for further consideration will be contacted and notified about the selection process
Dozvola za obavljanje djelatnosti u svezi sa zapošljavanjem ministarstva nadležnog za rad br. 178/20.
