Accountable for establishing and maintaining a local PV structure and related practices in compliance with local Regulation and in synergy with the clients Global PV system.
Responsible for the identification of outsourcing needs and the recruitment, onboarding, training, oversight and general end-to-end set-up of PV Operations Vendors and Service Providers; ensures alignment with applicable global oversight strategies for vendors, i.e. safety report reconciliation, vendor quality monitoring, monthly report etc.
Ensures appropriate storage and archiving of safety reports and training records
Authors local documents, such as Standard Operating Procedures (SOPs), Guidelines, Safety Management Plans/Manuals, Vendor Service Agreements, and ensures content alignment with GSRS procedures and Local PV requirements; ensures regular updates of these documents as per the established review cycles and as required according to enhancement needs.
Leads and collaborates with local Finance and Global Management on budget and resource planning for local PV activities.
Maintains a constant state of inspection readiness by maintaining appropriate documentation/evidence that demonstrates the efficient and compliant functioning of the local PV structure.
As required, contributes to projects related to any technical updates to PV practices (e.g. electronic submission of ICSRs to HAs).
Manages other local safety staff and resources as is applicable.
Contributes to and/or leads additional Local, Regional or Global strategic priorities, projects and responsibilities as required.
ICSR Management: Responsible for establishing optimum and harmonized processes for the receipt, collection and submission (as applicable) of Individual Case Safety Reports (ICSRs) for Company products from any source. Ensures procedures related to Literature Screening and ICSR Follow-up are in place.
Ensures ICSR submission is performed according to local requirements and tracks local regulatory submission of ICSRs and aggregate safety reports as necessary, in collaboration with medical reviewers.
Maintains close working connections with all local teams and functions; the primary point of contact to be consulted for all matters that impact PV within the affiliate; a standing member of relevant affiliate governance structures (as needed) to be kept up to date on local plans and projects that may have an impact on PV; provide strategic and operational recommendations to affiliate teams and projects to facilitate compliance with PV requirements.
Contributes to the global strategy for PV oversight and compliance management; implements effective measures to monitor compliance and quality of key local PV procedures and operations (including but not limited to ICSR collection and Health Authority (HA) submissions, as applicable) in the post-
marketing space in collaboration with International PV (IPV); incorporates the use of empirical data (both quantitative and qualitative) to drive continuous improvement of the local PV system.
Maintains awareness of all Organized Data Collection Programs (ODCPs) (such as Patient Support Programs (PSPs) and Market Research Programs (MRPs)), Extended Access Programs (EAPs), Compassionate Use (CU), Registries, Digital and Social Media Activities that are relevant to the local territory; ensures appropriate PV Processes are in place (e.g. Adverse Event Collection); ensures adherence with the Global PV Governance structure and procedures.
Serve as PV contact person in- and externally for local staff, GSRS and health authority
Responsible for the fulfillment of LQPPV Responsibilities as per local regulation; The LQPPV ensures there is comprehensive understanding of these specific responsibilities at the Local, Regional and Global level, in order to enable compliance with regulatory expectations for the role.
Acts as the local expert in all matters pertaining to PV within the post-marketing space and the aligned territory and provides strategic and operational consult to the local business. Contributes to PV matters in the Clinical space as required in collaboration with other GSRS functions. Contributes to the GSRS PV Regulatory Intelligence infrastructure by maintaining a detailed understanding and continuous awareness of the local PV Regulation / Guidance and any updates or changes; actively participates in relevant local trade associations, working groups and creates appropriate connections with local Health Authorities and influential institutions within the PV space.
Notify EU QPPV/GSRS of changes in local PV legislation/guidance, changes in PV personnel, and interactions with local Competent Authorities regarding safety issues.
Participates in any public consultations on planned changes to PV Regulation in close collaboration with International PV (IPV). Anticipate changes in PV Regulations and plans for changes in local procedure and templates accordingly.
Authors and maintains PV-related training and ensures regular delivery to all Affiliate staff, PV Operations Vendors and Service Providers including but not limited to training pertaining to AE collection responsibilities.
Assists GSRS with regulatory agency inquiries, CAPA investigation and implementation
Acts as the primary contact and Subject Matter Expert (SME) for local Audits and as required for local HA Inspections (including the interviewee role and collating responses to document requests); plays a lead role in the facilitation and coordination of local audits and inspections in collaboration with the applicable Quality teams; ensures there is timely and appropriate communication throughout the life-cycle of the Audit or Inspection to key Local and Global stakeholders including International PV (IPV); contributes as required to the Global Auditing strategy as it relates to the local territory.
The CSH is responsible for appropriate communication with local Health Authorities in partnership with other local functions (e.g. Regulatory Affairs and Medical Affairs); collaborates with regulatory colleagues to ensure safety notifications and submission of safety documents are performed in a compliant manner; coordinates with GSRS management to address safety related requests from the local HA.
Minimum of bachelor's level degree in nursing, pharmacy, or other health care related profession or life sciences required.
3-5 years in drug safety/pharmacovigilance in pharmaceutical industry setting or the equivalent for Manager Level above.
Proficiency in English and German
In-depth knowledge of Global, Regional and local PV regulations and requirements.
Excellent written and verbal communication skills including.
Well-developed technical writing skills with the ability to produce clear, concise documentation and communications. Good presentation and analytical skills.
Excellent Project Management skills.
Good proficiency with common software such as Microsoft Word, Excel, PowerPoint, Outlook.
Must work effectively/collaboratively in a fast-paced and matrixed environment.
Individual has effective managerial skills (as applicable to job roles and scope), is a self-starter, ability to adapt - to work independently or as part of a team, goal oriented, attention to detail and accuracy, and ability to multitask and prioritize.
Strong decision-making skills required.
Must demonstrate initiative to effectively identify and communicate issues.
Individuals should be able to demonstrate innovative thinking.
Knowledge of Good PV Practices
Direct experience in GxP compliant quality systems preferred
Experience with interacting with third parties (e.g PV operations vendors) required
Experience with Adverse Events Intake systems
Experience in writing procedures, training materials and effectively delivering training to a diverse audience
Experience (e.g. interviewee, control room, document request) of Audits and Regulatory Inspections preferred.