Senior pharmacovigilance Specialist At Viatris
The Senior PV Specialist
The Senior PV Specialist is responsible to organize, implement, and maintain the Affiliate PV System.
After Hours Availability
Ensure after-hours availability if required by the local regulation.
ICSR handling
Ensures that local processes, procedures and systems are in place for Individual Case Safety
Report (ICSR) management including receipt, documentation, forwarding to PSRM PVOperations, tracking, follow up etc.
Ensure collection of safety data and other PV-related responsibilities in relation tointerventional studies (clinical trials)
Ensure collection of safety data and other PV-related responsibilities in relation to organized data collection schemes including, non-interventional studies, registries, customer engagement programs (CEPs) etc.
Ensures screening of Viatris-sponsored social media (web sites, web pages, blogs, vlogs, social networks, internet forums, chat rooms or health portals) for safety information.
Ensures screening of local language medical or scientific literature, not included in PSRMglobal iiterature review.
Ensures that patient confidentiality and privacy in accordance with local applicable laws and regulations are adhered to.
Ensures handling of safety information
Periodic Safety Reporting
lnforms Safety Systems Team (SST) about the requirement/ change in requirement of any Periodic Safety Update.
Report (PSUR) in liaison with local regulatory affairs.
Provides safety information required for preparation of periodic safety report, upon request to SST.
Compliance
Ensures a local tracking system is in place, to ensure timely submissions of ICSRs to PV Operations.
Monitors Affiliate PV system performance and compliance. Reports monthly compliance metrics to Global PSRM.
Maintains awareness of local PV legislation and of relevant international legislations, regulations and guidelines.
Ensures tracking and communicating changes in local PV regulations that may have an impact on standards and procedures of Global PSRM.
Maintains compliance with local agreements, including reconciliation and safety data exchange between partner companies.
Completes monthly ICSR reconciliation with interacting functions and/or departments, including medical information, product complaints.
Ensures functionality check of common PV mailboxes, phone numbers used for medical information/PV and fax number.
Ensures any changes to Affiliate PV personnel are communicated to the regulatory authority and relevant Global PSRM personnel in a timely fashion.
Ensures local deviation procedure is in place to document necessary planned departures from procedures and to be used when managing non-conformities.
arising from product complaints (in association withQA).
Training
Maintains a version-controlled training matrix for local PV personnel.
Ensures basic PV training of new Affiliate employees and refresher training at least annually andthat appropriate training records are maintained.
Ensures relevant training of new PV staff.
Ensures training on and compliance to global and local SOPs, and relevant regulations and legislations.
Ensures that any training of partner company staff is completed according to local contract requirements and appropriately documented.
Creates PV training material where applicable and Approves PV Training material authored by others.
SOPs
Ensure implementation of PSRM standards and procedures, as applicable.
Ensures local processes and procedures are developed and implemented to define pharmacovigilance responsibilities in line with PSRM standards and procedures, as weIl as local regulations, as applicable.
Audits and Inspections
Be the key Affiliate contact for both internal PV audits and regulatory authority PV inspections.
Ensures that any regulatory authority communications are forwarded to the required PSRM personnel and that any corrective actions are completed according to schedule.
Safety Data Exchange (SDE) Agreements and other PV agreements
Ensures a local process is in place for management of local SDEAs and PV agreements that conforms to Viatris Standards per global procedures and local requirements.
Ensures that PV matters are appropriately considered during selection of service provider and in the contractual arrangements when subcontracting PV activities.
Risk Management Plan
Ensures local implementation and tracking of activities in accordance with Risk Management Plans (RMPs)
Safety inquiries
Ensures handling of inquiries relating to product safety including regulatory authority inquiries.
I nforms Regional Leads concerning urgent safety restrictions.
Safety Signals
Informs SST about any potential signal or safety concern identified at local level.
PV business continuity
Ensures to planning of PV business continuity and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance.
Archiving
Ensures record retention of all PV related data and documents according to Viatris Global requirements and national requirements.