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Safety and Regulatory Affairs Officer (m/f)
Adecco is a global leader in providing HR services.
For our client, a pharmaceutical company specializing in the distribution and marketing of pharmaceutical products, we are looking for:
Safety and Regulatory Affairs Officer (m/ž)
WHAT YOU'LL DO:
- Acting as deputy of local person responsible for pharmacovigilance (LQPPV)
- Communication with partners (MAHs) and NCA for PV related issues
- Maintenance of local PV SOPs, policies and work instructions
- Participation in the process of collecting, validating, forwarding and recording of safety information (adverse drug reactions, special situations)
- Participation in the local literature monitoring process (communication with service provider, recording of the weekly results)
- Preparation of the additional risk minimization measures (armm) documentation
- Preparation/translation of SmPC, PIL and labelling for safety variation submissions
- Conducting PV trainings for company employees, wholesalers, service providers etc.
- Attendance of PV trainings organized by partners (MAHs) and NCA
- Continuous monitoring of local PV legislation
- Participating in PV audits and inspections
- Preparation of corrective and preventative measures (CAPA) within agreed deadlines
- Proper recording of different PV documentation and activities
- Review and approval of product information (labelling), artwork review and approval for medicinal products, medical devices, food supplements and cosmetic products
- Notification and registration of food supplements and medical devices to NCA
- Continuous monitoring of local and EU legislation for medicinal products, medical devices, food supplements and cosmetics
- Preparation of local documentation (product information, cover letters, application forms, proofs of payment) within the process of variations submission
- Timely distribution of local Product Information within the company
- Communication with partners (MAHs) and NCA for RA related issues
- Attendance of RA trainings and meetings organized by partners (MAHs) and NCA
- Participation in the activities related to vigilance of medical devices, nutrivigilance and cosmetovigilance
- Maintenance of local QA SOPs, policies and work instructions
- Participation in the process of collecting, validating, forwarding and recording of product complaints
- Participation in the product recall processes
- Participation in vendor assessment processes
- Preparation of Business Continuity Plan (BCP) and related documents
- Proper recording of different QA documentation and activities
WHAT WE OFFER:
- Indefinite-term contract with a probation period
- Pleasant working atmosphere in an international environment
- Attractive salary
- Great learning possibilities
WHAT YOU'LL NEED:
- Doctor of medical science, or a doctor of dental medicine, or a graduate pharmacist, or a master of medical biochemistry, or a doctor of veterinary medicine with 2-3 years of experience in pharmacovigilance/regulatory affairs
- Fluency in English (verbal and written)
- Experienced MS Office (Word, Excel, Power Point) user
- High organizational skills with the ability to meet strict deadlines and effectively manage competing priorities
We're looking for a talented and dedicated Safety and Regulatory Affairs professional. If you're
passionate about ensuring product safety, regulatory and quality, then we want to hear from
Take the next step in your career and apply now, send us your CV in English via application link.
Note: Please mind that only the candidates selected for further consideration will be contacted and notified about the selection process
Adecco Hrvatska d.o.o. is licensed by the Ministry of Economy, Labor and Entrepreneurship for executing mediation services in employment No. UP/I-102-02/20-03/13 since 13.02.2020.