Kristina Malec

• Responsible for establishing and implementing the pharmacovigilance
system for marketing authorization holder (MAH)
• Establishment, development, and maintenance of the Master file of the pharmacovigilance system (PSMF)
• Maintaining and improving compliance and the quality system in a PV system
• Overview of safety profiles and all safety concerns for all authorized products of the MAH
• Contact person for pharmacovigilance inspection• Preparing, obtaining and/or forwarding of the safety documents that are to be submitted to the Agency (ICSR, PSUR, PASS, DSUR,RMP, RMM, DHPC)
• Continuous post-marketing safety evaluation of medicinal products• Ensuring a full and prompt response to any request from the competent authorities
• The activities of the responsible person for pharmacovigilance (QPPV) of marketing authorization holder (MAH) have to ensure the functioning of pharmacovigilance system

• Medical review and quality control of academic articles
• Medical review and quality control of individual case safety reports (ICSRs)
• Medical review and quality control of Summary of Product Characteristics (SmPC), recommendations for safety changes

• Participation in and/or evaluation of safety signals and benefit-risk
ratio of a particular medicinal product

• Participation in coordinating, directing and developing company activities and processes in the area
of business development, finding new clients, and external and internal company communications;
participation in market positioning by locating, developing, defining, negotiating and concluding
business relationships in the Republic of Croatia and other countries where Marti Farm d.o.o. has
clients and partners
• Identifying new ideas by exploring the industry and related events, publications and advertisements in cooperation with other team members
• Recognizing and suggesting potential business liaisons by contacting potential clients; investigating
and discovering new business opportunities
• Gaining experience in all business and research aspects related to industry trends; managing,
organising and assisting in certain company projects
• Preparing and reviewing memos and outbound mail; corresponding with clients, service providers
and other associates or interested parties; preparing , proposals, implementing promotional activities in accordance with the development strategy
• Organising, attending and conducting meetings; preparing for meetings by investigating,
organising and reviewing relevant materials
• Connecting with clients, providers and other associates in and outside the company
• Developing negotiation and positioning strategies by investigating the integration of new undertakings into the company’s business strategy; exploring risks and potentials; assessing partner needs and objectives
• Negotiating new business opportunities by coordinating requests; developing and concluding contracts; integrating contractual terms into business operations
• Retaining company values by keeping information confidential
• Upgrading professional knowledge by participating in educational opportunities; maintaining a personal network of business contacts

• Independent management of local and global pharmacovigilance projects, acting as Project
Manager
• Monitoring regulatory authorities’ websites;
• Review of PRAC and European database of suspected adverse drug reaction reports;
• Processing individual case safety reports (ICSRs) and requesting follow-up information from
spontaneous and solicited sources;
• Participating in preparation of PSMFs and maintenance thereof:
• Preparation of monthly reports on performed pharmacovigilance activities for clients;
• Communicating with clients, participation at meetings;
• Preparing and updating plans for the submission of periodic reports and RMPs;
• Participation in and/or production of periodic reports (PSUR, Addendum to the Clinical Overview);
• Participation in and/or preparation of SOPs;
• Participation in and/or preparation, review and revision of SmPC and PIL;
• Participation in and/or preparation of RMPs;
• Preparation of documents and registration of responsible persons for pharmacovigilance;
• Assisting in registration of clients in EudraVigilance;
• Data entry into XEVMPD;
• Participating in the preparation of direct healthcare professional communication (DHCP);
• Educating junior associates in the regulatory department;
• Take part in audits and inspections for clients and preparation thereof.

• Providing support to other activities undertaken by the project team
• Support of PV processes related to the ICSR management within the company and to clients
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe
• Workflow management
•Database testing

• Processing Individual Case Safety Reports (ICSRs) and follow-ups
• Archiving all ICSR documentation, according to PrimeVigilance SOPs and timeframes
• Maintenance of own training record

Laboratory work: PCR (Polymeras chain reaction), DNA manipulation, gel electrophorisis and DNA
extraction, DNA restriction, Ligation, Bacterial cell transformation, plasmid DNA isolation, DNA
quantification, cell culture manipulation, cell lines transfection, cholinesterase activity
determination, recombinant enzymes purification, IMAC chromatography, SDS-PAGE, protein
concentration determination, semi-dry western blotting, antibody detection, bioinformatics

BSA essay, Ellman method, SDS-page, Native electrophoresis