LOCAL SAFETY OFFICER - UKRAINE

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Position Summary.
The incumbent is responsible for supporting Pharmacovigilance-related activities in the Ukraine, Georgia, and Azerbaijan countries as required by Marketing Authorization Holders (MAH) and/or study sponsors, as applicable.
Also, it will ensure the maintenance of an appropriate PV, vigilance system, and Risk Management to ensure appropriate oversight for products within its responsibilities.
Ensure the pro-active Benefit Risk Management throughout product life cycle translating global safety data to insights and actions tailoring to local specificities and needs.
Main responsibilities.
Act as Local Nominated Person Act as nationally nominated person for Pharmacovigilance assuming the PV role as defined by national law.
Collaborate with the QPPV office as required Local Medical Safety Responsibility & Benefit Risk Management Establish Product knowledge with a focus on safety profiles, Therapeutic Areas, and Disease Pathway knowledge supporting the needs of the local Medical and Marketing organization in collaboration with the International Medical Safety leader or MSO and the Country Safety team lead (CSTL), as applicable.
Safety Management & Reporting Accountable for ensuring that the Local Operating Company (LOC) meets procedurally defined timelines for the management of safety information and any local regulatory agency-defined timeline for submission of individual case safety reports.
Establish adequate collaboration with the Case management team to maintain local compliance oversight on case processing, follow-up requests, reconciliation, submission, and local literature search.
Aggregate reports.
Plan and ensure timely submission of Aggregate Reports according to local regulations Ensure with the case management team that local data are provided as required to support the preparation of Aggregate Safety Summary reports (PSUR, DSUR, etc.).
Plan and ensure timely submission of Aggregate Reports according to local regulations.
Provide due dates to Global Medical Safety (GMS) and promote synchronization with the Global PSUR schedule, in accordance with national requirements and in collaboration with the Local Regulatory Affairs unit.
Pharmacovigilance-Safety training Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
PV contract management.
Perform contract review in collaboration with the Hub if applicable and maintain oversight on the commercial and vendor agreements to ensure safety reporting obligations are defined and integrated into case handling procedures, as necessary.
Coordinate the provision of support for third-party safety agreements locally e.
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local Vendor Agreements, as necessary, and seek support from central functions like PV Service and Technical Contracts Group and International PV(IPV) Affairs as needed.
Signal Detection Ensure adequate local signal detection process if required and ensure reporting of potential single case signals or clusters of similar events seen in case processing, as applicable and in collaboration with the Case management team.
PSMF contribution.
Provide timely and accurate PSMF contribution for EU PSMF.
Ensure the adequate process is established for the implementation and the maintenance of the local “PSMF”, where applicable Safety regulations.
Ensure awareness of changes in regulations which may have an impact on vigilance activities and responsibilities.
Evaluate the impact on local processes and inform the appropriate global and regional groups (i.
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QPPV offices and Regional Cross-Sector Safety Head) of any changes to local laws and regulations regarding safety.
Procedural Document Management Ensure implementation of pharmacovigilance-relevant Procedural Documents as applicable and/or write, validate, and implement the Local Implementation Documents (LID) for Regional / International PV Standard Operating Procedures/Working Practices and verify adherence.
Where appropriate develop local controlled procedures to cover local aspects of pharmacovigilance / Safety activities.
Business Continuity Ensure creation and implementation of local business continuity plans (e.
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inspection readiness, AE reporting coverage) in collaboration with the case management team.
Ensure an effective system is in place for 24-hour coverage.
Ensure that day-to-day PV functions are performed satisfactorily and that optimal regulatory compliance is maintained at the LOC level in collaboration with the case management team.
Local Safety compliance.
Establish adequate collaboration with case management team to maintain local compliance and local compliance oversight on case processing, reconciliation, and submission to Regulatory Authorities Provide insights into metrics to local management and IPV, lead actions as needed.
Collaborate with local Commercial Quality organizations to ensure oversight on local CAPA with potential impact on pharmacovigilance Maintain oversight of CAPAs that could impact local processes Clinical activities compliance Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols or Patient Support Programs (PSP) to ensure appropriate safety reporting to Global Medical Safety (GMS) and Regulatory Authority (RA), as required.
Pharmacovigilance and Vigilance Service Provision.
Ensure that day-to-day Pharmacovigilance and safety activities are performed satisfactorily and that full regulatory compliance is maintained at the Local Operating Company level including adequate record management.
Inspection and Audit preparation & support Always ensure PV audit & inspection readiness on the LOC level.
Act as the local PV contact person for local PV audit and inspection.
Collaborate with local/cluster case management team to ensure LOC/LSU audit and inspection readiness.
Assist inspectors/auditors, and support document requests in collaboration with the case management team.
Address follow-up actions from findings.
Qualifications Qualification & Experience Minimum of 3 years of pharmacovigilance experience in the pharmaceutical industry Advanced Degree in medicine or life sciences/ Pharmacy (B, Pharm or D, Pharm) preferred Experience in pharmaceutical regulations and R&D processes is preferred.
Knowledge and familiarity with industry principles of product vigilance, drug development, and pharmacology Proficiency in Medical terminology (local languages) Knowledge & Skills Good verbal and written communication skills, proficiency in local language(s) and English language required Good in data analysis and reporting Proficiency in global and local SOPs Ability to negotiate and communicate with internal and external customers.
Ability to establish and maintain open relationships within the organization and with authorities.
Ability to manage multiple critical issues and work under pressure We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment.
Please contact us to request accommodation.
Johnson & Johnson Family of Companies are equal opportunity employers and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences That is why we in Ukraine are working to create an inclusive environment where a diverse set of backgrounds, perspectives, and experiences are valued and each and every one of our people feel that they belong and can reach their potential.
No matter who they are.
Diversity, Equity and inclusion at Johnson & Johnson means “You Belong”! When appointing potential candidates in Ukraine, the Employment Equity and Broad-Based Black Economic Empowerment Legislation will be considered