Company Description

The Country Safety Lead (CSL) is the primary Pharmacovigilance (PV) point of contact for the local territory. The CSL is responsible for the end-to-end operation, management and oversight of local PV tasks in compliance with all applicable local regulations, guidances and global business requirements. The CSL is a key strategic partner for the local business and provides valued consult and collaboration to all affiliate stakeholders and functions to support local objectives. The CSL also contributes to the Global and Regional PV strategy as required.

Job Description

Accountable for establishing and maintaining a local PV structure and related practices in compliance with local Regulation and in synergy with Biogen's Global PV system.

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.

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.

Maintains awareness of all Organised 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.

Where local signal management is mandated by local Regulation, oversee and manage the process to ensure compliance; collaborate with GSRS teams as required to address any outcomes and concerns.

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.

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.

Leads and collaborates with local Finance and Global Management on budget and resource planning for local PV activities.

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.

Maintains a constant state of inspection readiness by maintaining appropriate documentation/evidence that demonstrates the efficient and compliant functioning of the local PV structure.

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.

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.

Contributes to the GSRS PV Regulatory Intelligence infrastructure by maintaining a detailed understanding and continuous awareness of the local PV Regulation 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.

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.

As required, contributes to projects related to any technical updates to PV practices (e.g. electronic submission of ICSRs to HAs).

Fosters an environment of sharing best practices, learnings and innovations with the wider PV and Regulatory affiliate network.

The CSL 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.

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.

As is applicable the CSL is also 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.

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.

Qualifications

To demonstrate sccess in this role you will come from a similar Pharmacovigilance Lead role within a pharmaceutical organisation.

Along with a degree in nursing, pharmacy, or other health care related profession or life sciences you will also possessthe following:

Experience with interacting with third parties (e.g. PV operations vendors) required
Knowledge of Good PV Practices
Direct experience in GxP compliant quality systems preferred
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.
In-depth knowledge of Global, Regional and local PV regulations and requirements.
Excellent written and verbal communication skills.
Well-developed technical writing skills with the ability to produce clear, concise documentation and communications. Good presentation and analytical skills.
Excellent Project Management skills.
Strong Information Technology (IT skills); familiar with common software such as Microsoft Word, Excel, PowerPoint, Outlook.
The ability to work effectively/collaboratively in a fast-paced and matrixed environment.
Effective managerial skills (as applicable to job role 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 multi-task and prioritize.
Strong decision-making skills.
The initiative to effectively identify and communicate issues.
Innovative thinking.

At Biogen ANZ we embrace an inclusive workplace andapplicants of all backgrounds and experiences.However due to current Covid19 border restrictions and uncertainty; we are unable to sponsor offshore applicants at this timeand only applicants who have unlimited working rights in Australia will be considered.

Additional Information

Roles like this don't come up very often! Fantastic opportunity to join our vibrant Sydney based office as a Pharmacovigilance expert in this 12 month contract position

Country Safety Lead (12 month parental leave contract)

Biogen Australia and New Zealand • North Ryde NSW 2113

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Biogen Australia and New Zealand
• North Ryde NSW 2113