For our Global Safety andPharmacovigilance department, we are looking fora
Regional Safety Officer (RSO)Germany & Austria (m/f/x)
R-248156
Fulltime / permanent
The primary objective of the DACH (Germany and Austria)Regional Safety Officer position is to manage the localpharmacovigilance (PV) system(s) in the CSL enterprise (Behring,Seqirus and Vifor) ensuring compliance with applicable PVregulations and guidelines as well as corporate and Global Safety& Pharmacovigilance (GSPV) policies. This role is strictlynon-promotional and operates in alignment with the principles ofCSL’s Global Safety Governance System to ensure maintenance of thecompany’s license to operate.
TheOpportunity
* Establishes and maintains local PV systems in compliancewith national regulations and GSPV policies. Leverages a diverseand robust set of sources including but not limited to regulatoryintelligence, continuous improvement initiatives, key performanceindicators (KPIs) as well as audit / inspection findings, to evolveand enhance the local PV system.
* Ensures comprehensive oversight of all localpharmacovigilance (PV) activities conducted at CSL, and establishesa robust framework for assessing potential risks, monitoringtrends, and managing emerging issues.
* Maintains close liaison with the EU QPPV,Graduated Plan Officer (Germany) and IPV Head of Europe. Act as theGraduated Plan Officer or deputy and fulfill the legal requirementsin accordance with section 63a of German Medicine AMG, 12, 19 AMWHVas and when required.
* Responsible for the establishment, maintenance, andoversight of local Pharmacovigilance (PV) processes, including butnot limited to:
* Management of Individual Case Safety Reports (ICSRs),encompassing their handling, reporting, and follow-up, as well ascompliance oversight where applicable.
* Reconciliation of ICSRs with relevant internalstakeholders, such as Global Case Management, local Quality,Medical Information and Sales Force, as well as third parties(e.g., distributors, Medical Information vendors, Organised DataCollection Systems (ODCS), service providers, etc.).
* Regular screening of localliterature, ensuring that all identified safety information ismanaged in accordance with local and global processes.
* Maintains up-to-date informationrelevant for the Pharmacovigilance System Master File (PSMF) orlocal PSMF as required by local regulations.
* Oversight of the submission status of aggregatereports (e.g., PSURs) to the relevant regulatory authorities, aswell as the preparation or contribution to local aggregate reports,Risk Management Plans (RMPs), and supporting documents wherenecessary.
* Implementationof additional risk minimization measures (aRMMs), whereapplicable.
* PV oversightof local digital and social media channels.
* Ensuring the existence and regular testing of alocal PV business continuity plan.
* Documentation of local PV activities in appropriateprocedures and records.
* Storage and archiving of PV-related documents and recordsin GXP validated repository.
* Conducting local reportability assessments and thereporting of signals and urgent safety information to localregulatory authorities as required.
* Providing guidance to direct reports on theexecution of local PV processes.
* Acts as a primary point of contact for all PV-relatedmatters in their territory/region, and timely communication andescalation of PV-relevant issues as per established local andglobal processes.
* Responsible for ensuring awareness and compliance withcurrent PV regulations and guidelines. Oversees the localassessment, communication, and implementation of new or updated PVrequirements, including notifying Global of local reportingobligations to ensure the Global Safety Database remains compliant.Provides advice to management and updates controlled documents andplatforms to align with evolving regulations.
* Establishes good working relationships withGSPV, Global Regulatory Affairs (GRA) and local functions, such asLocal Quality Officer (e.g., for PTCs), Marketing and MedicalAffairs (e.g., for ODCSs), Commercial Operations, Research &Development Quality Assurance (R&DQA;) and Clinical.
* Maintains up-to-date understandingof safety profiles of registered and investigational products.Supports and collaborates with cross-functional teams to identifyand investigate safety concerns, contributing to the evaluation ofproduct safety risks.
* Participates in internal meetings regarding product safetyas applicable.
* Participates in local Commercial Operations LeadershipTeam meetings as required and provides input to strategic planningdiscussions as needed, ensuring alignment of PV activities withbroader organizational objectives.
* Ensures appropriate pharmacovigilance oversight of allOrganized Data Collection Systems (ODCS) within the territory,ensuring adherence to relevant processes. Facilitates theimplementation of Pharmacovigilance Agreements (PVAs) in closecollaboration with the relevant Global Safety and Pharmacovigilance(GSPV) functions and local teams e.g. Global PharmacovigilanceAgreements and Alliance (GPAA) and International Partner Markets(IPM) team.
* Responsiblefor the management and oversight of third-party subcontractedactivities, maintaining local control and accountability.
* Conducts reviews of relevantQuality Agreements with business partners, ensuringpharmacovigilance obligations are incorporated into PVAs as neededin collaboration with GPAA.
* Key PV point of contact for local PV inspection bycompetent Regulatory Authorities and/or PV affiliate audits in theterritory, in collaboration with LSOs, CSL QPPV, GSPV IPV, PVRQA,and relevant local functions.
* Ensures audit/inspection preparation and close-outactivities including the development of a CAPA plan and the closeout of any audit/inspection action items.
* Responsible as the follow-up coordinator forCAPAs raised and for the close out of audit action items, wherenecessary.
* Manages PVtraining requirements of affiliate personnel and personnel ofrelevant 3rd party service providers, ensuring these personnel areaware of their PV reporting obligations. This includes developmentof training materials with IPV, delivery of regular and ad-hoctraining, and monitoring of training compliance.
Your Skills andExperience
* Degree in life science, nursing, pharmacy, or otherrelated area; OR Equivalent experience
* Qualification in line with relevant locallegislation
* Experience inthe pharma industry, and knowledge in pharmacovigilance; OREquivalent experience in line with relevant locallegislation
* Good verbaland written communication skills in English
* Fluent in local language(s) of territory ifrequired by legislation
* Travel Requirements: Domestic and/orinternational
What we offer
* Excellent income potential and extendedbenefits
* Two additional leave days for yourpersonal wellbeing
* Family services such aspsychological support, legal advice, family care services and morefor you and your direct family
* Hybrid workingmodels
For more information, pleasecheck out our global benefits below
We arelooking forward to your application. Please ensure to apply onlinewith your CV and certifications as well as your salaryexpectation.
OurBenefits
We encourage you tomake your well-being a priority. It’s important and so are you.Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing anddelivering high-quality medicines that treat people with rare andserious diseases. Our treatments offer promise for people in morethan 100 countries living with conditions in the immunology,hematology, cardiovascular and metabolic, respiratory, andtransplant therapeutic areas. Learn more about CSLBehring.
We want CSL to reflectthe world around us
As a globalorganisation with employees in 35+ countries, CSL embracesdiversity and inclusion. Learn more about Diversity & Inclusionat CSL.
Do work that matters atCSL Behring!