Safety and Regulatory Affairs Officer m/f

Opis posla

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/f
Location: Zagreb

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 you.

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.