Milica Zhugich

Experience

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  Medical sales representative and community pharmacist

  Dec 2006 - Jul 2011

  Prior positions
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  Novo Nordisk A/S

  Jul 2011 - Jul 2012

  Clinical Research Associate

  • Monitored clinical trials to ensure compliance with the clinical trial protocol, checked clinical site activities, performed source data verification (SDV) to secure data reliability, checked correctness/completeness of all entries to study documentation (CRFs), checked the conditions of storage and trial medication usage (drug accountability) within the trials• Managed different projects simultaneously while delivering against ambitious goals• Provided support to investigators in all aspects of the trial conduct• Reviewed all study documents including the protocol, informed consent form, source documents, study specific procedures Show less

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  Pharmacy "Alpi Farm"

  Nov 2012 - Oct 2013

  Pharmacist

  • Filled prescriptions, dispensed OTCs and provided relevant information/counseling patients on their therapy, nutritional counseling• Performed drug safety monitoring and reporting• Managed and safeguarded legal and financial records• Managed coding, stocking and ensured storage conditions were appropriate

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  Farmio Com DOOEL

  Oct 2013 - Jul 2015

  Regulatory, Quality Assurance and Pharmacovigilance Officer

  • AbbVie dedicated person• Oversaw Quality Assurance function, wrote Standard Operating Procedures, maintained budget and managed filing and archiving• Developed and tracked quality metrics• Established and maintained PV system; performed QPPV role• Attained 100% compliance in local and worldwide ADRs submission as well as submission of PSURs and RMPs• Maintained knowledge of existing and emerging regulations, standards, or guidance documents• Strategically negotiated a more direct, convenient and cost-effective pathway with the drug agency allowing for increased efficiency and profitability Show less

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  Ewopharma

  Aug 2015 - Aug 2017

  Regulatory, Pharmacovigilance, Quality Assurance and Compliance Officer

  • Obtained numerous Marketing Authorizations for drugs, borderline products and Renewals for Medical Devices within the timelines• Devised a submission strategy that drastically reduced approval times• Accomplished 100% compliance in local and worldwide ADRs submission as well as submission of PSURs and RMPs• Worked on and finalized PV Contracts• Wrote and developed numerous Pharmacovigilance, Quality Assurance, Medical and Regulatory SOPs as well as the Business Continuity Plan• Delivered savings and increased productivity by clarifying deficiencies• Performed QPPV role• Identified problems and implemented CAPA preparation/investigation and resolution Show less

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  Scarborough and Rouge Hospital

  Jun 2018 - Aug 2018

  Volunteer

  Supply Chain Management

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  PharmaLex

  Dec 2018 - Mar 2022

  • Served as Deputy EU QPPV and Project Lead for post-marketing pharmacovigilance projects, driving the establishment, oversight, and continuous improvement of the PV system, ensuring full compliance with regulatory standards. Successfully managed the PSMF and coordinated the development of critical documents such as SOPs, WIs, PSURs, RMPs, and signal detection reports, considering the safety profiles of the medicinal products and the changing regulatory requirements.• Managed PV Agreements/SDEAs, ensuring effective partnerships and seamless collaboration with stakeholders.• Acted as a point of contact for Competent Authorities, ensuring full and prompt responses to all regulatory requests.• Led end-to-end project management for PV projects, from start-up to close-out, delivering projects on time and within budget. Successfully prepared and tracked project timelines, deliverables, metrics, and KPIs. Actively participated in process improvement initiatives, driving the implementation of lessons learned to enhance future project execution.• Assumed quality assurance responsibilities, serving as a PV auditor-in-training, contributing to the continuous improvement of internal processes and ensuring audit and inspection readiness.• Oversaw vendor qualification and management, optimizing vendor performance and ensuring that partnerships met the highest PV standards.• Led the Bulgarian affiliate PV team, fostering a collaborative and high-performing team environment that consistently exceeded expectations.• Supported business development efforts, as part of the local PV services team via identifying relevant local PV regulations for marketing authorization and post-marketing PV activities. Show less • Led post-marketing pharmacovigilance (PV) projects as Project Lead and Deputy EU QPPV, driving the successful execution and oversight of critical safety monitoring activities for multiple clients.• Managed case intake, literature searches, and coordinated the preparation of key regulatory documents including PSURs, DSURs, PSMFs, RMPs, and signal detection reports.• Supervised KPI compliance, ensuring all safety metrics were consistently met or exceeded. Managed CAPAs, non-conformities, and complaints, driving root cause analysis and corrective actions that resulted in reduction in non-compliance incidents.• Led the development, maintenance, and periodic review of procedural documents, ensuring they aligned with evolving regulatory standards and driving continuous improvement across PV operations. Show less

  • Pharmacovigilance Manager (deputy) EU QPPV

    Apr 2020 - Mar 2022

  • Regulatory Affairs Specialist, Senior PV Specialist, (deputy) QPPV and QA Specialist

    Dec 2018 - Apr 2020
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  PrimeVigilance Ltd.

  Mar 2022 - Dec 2022

  Client Quality Manager

  • Led the implementation and maintenance of the PV quality system, hosting audits and managing CAPA processes to ensure continuous improvement and regulatory compliance.• Ensured compliance with global and local pharmacovigilance regulations, as well as PrimeVigilance and client requirements, achieving successful outcomes in all audits.• Drove process improvement initiatives through the measurement and analysis of quality and compliance, conducting periodic reviews of KPIs, deviations, and findings to predict potential issues and seize opportunities for optimization, resulting in increased process efficiency.• Created and maintained project-specific Quality Management Plans (QMPs) for each assigned project, enhancing overall project alignment and ensuring consistent quality standards across all client deliverables. Show less

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  Excelya

  Dec 2022 - now

  LSSO/Safety Project Leader

  • Led and successfully managed post-marketing pharmacovigilance (PV) projects, coordinating international teams of local QPPVs/LCPPVs across multiple clients to ensure consistent safety monitoring and compliance, while improving team coherence and communication lines to enhance overall project efficiency.• Served as the primary point of contact for pharmacovigilance with the Bulgarian Drug Agency, facilitating smooth regulatory interactions and ensuring compliance with local and EU PV requirements.• Implemented and maintained an efficient local PV system, driving continuous compliance and performance improvements that resulted in a 5-fold increase in locally reported ADRs. Collaborating with third-party vendors to streamline reporting and response times, resulting in enhanced safety data quality and faster issue resolution.• Led the approval and implementation of Risk Minimization Measures (aRMMs), significantly reducing regulatory approval time.• Ensured audit and inspection readiness, actively participating in audits and inspections, achieving consistent positive results.• Managed deviations and Corrective and Preventive Actions (CAPAs), driving process improvements that led to increase in operational efficiency and reduced non-compliance incidents.• Led the negotiation and management of PV Agreements/SDEAs, ensuring timely and accurate execution and driving improvements in vendor relationships.• Successfully set up and qualified new PV vendors, enhancing the company's network of trusted partners and improving the scalability and reliability of safety monitoring operations. Show less