We are currently hiring a Country Safety Lead for our new Biogen entity in India.
As one of the first hires of this new set-up, the CSL, India, is the primary Pharmacovigilance (PV) point of contact for the local territory, fulfilling the regulatory mandated role of the Pharmacovigilance Officer in Charge (PVOIC)in India. The CSL is responsible for the end-to-end setup, operation, management and oversight of local PV tasks in compliance with all applicable local regulations, guidance and global business requirements. The CSL is a key strategic partner for the local business and provides valued consult and collaboration to all PV affiliate stakeholders and global functions to support local, regional and global PV objectives. The CSL also contributes to the Global and Regional PV strategy as required.
Responsibilities:
Accountable for establishing and maintaining a local/regional PV structure and related practices in compliance with local Regulation and in synergy with Biogen’s Global PV system.
Acts as the local/regional 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 Safety and Regulatory Operations, Medical Writing, and Benefit Risk Management (SABR) 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 Local Literature Screening and ICSR Follow-up are in place.
Where applicable, ensures Health Authority submission compliance of Aggregate Reports; maintains an up-to-date knowledge of local regulatory requirements for Aggregate Reporting and effectively communicates all related Regulatory intelligence to the International Pharmacovigilance (IPV) team and other SABR functions as concerned and collaborates as required 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.
Where local signal management is mandated by local Regulation, oversee and manage the process to ensure compliance; collaborate with SABR teams as required to address any outcomes and concerns.
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, Service Providers and other third parties; ensures alignment with applicable global oversight strategies for vendors.
Leads and collaborates with local Finance and IPV 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 SABR procedures and Local PV requirements; ensures regular updates of these documents as per the established review cycles and as required according to enhancement needs.
Where required, creates and maintains the local Pharmacovigilance System Master File (PSMF) in accordance with the GVP requirements and as appropriate internal business processes. Ensures that the local PSMF is kept up to date and ready for submission to local authorities at all times.
Maintains a constant state of inspection readiness by maintaining appropriate documentation/evidence that demonstrates the efficient and compliant functioning of the local PV structure. Acts as the lead PV contact (and hosts where needed) local Pre and Post-Marketing inspections throughout the inspection lifecycle.
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 SABR 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 SABR management to address safety related requests from the local HA; maintains awareness, contributes and collaborates with the relevant affiliate and SABR functions as it relates to the management and communication of Product Recalls, Urgent Safety Measures and Urgent Safety Restrictions related to the local territory. Additional responsibilities also include the below:
Maintains awareness of legal cases pertaining to the local territory; ensures all ICSR related information is managed according to Biogen procedures; ensures IPV regional management are kept informed in a timely manner; contributes local pharmacovigilance expertise as required and appropriate in support of Global PV, local and global litigation functions.
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 Local Pharmacovigilance Officer in Charge (PVOIC) Responsibilities as per local regulation; The PVOIC 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.
Completes relevant and on-time training on Biogen’s PV system prior to commencement of local QPPV responsibilities.
Utilize core/reference RMPs and other sources to produce local Risk Management Plans (RMPs) in accordance with local requirements. Engage with relevant stakeholder in the development of local Risk Minimization Measures (RMMs) and RMP Commitments as needed.
Ensures that all PV registrations with regulatory authorities are accurate and up to date at all times (e.g. Registration of the LQPPV details)
Quality tasks (for limited time)
Identify and monitor regulations and licensing requirements for commercial distribution
Support coordination of health authority inspections and Partner audits at Biogen International, if required
Review of RFP responses during selection of potential distribution partners
Support quality readiness relating to distribution to enable launch timelines (e.g. Change Controls, Quality Agreements, QMS, distribution model, etc.)
Identify requirements for method transfers supporting country testing and release.
Minimum Requirements:
Minimum of bachelor’s level degree, in pharmacy medicine
5+ years in drug safety/pharmacovigilance in pharmaceutical industry setting or the equivalent for Sr. Manager Level above
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.
Job Level: Management
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
