General Pharmacovigilance activities/Compliance:
· Ensure that PV requirements are performed at the local level. This includes Affiliate PV activities, the implementation of GPV policies and SOPs as applicable, implementation of Affiliate SOPs, PV training for all local staff (including sales representatives) and archiving of Affiliate PV documents.
· Ensure implementation of changes in GPV policies and SOPs in Affiliate SOPs as applicable within 60 days of global documents becoming effective.
· Regularly check the Affiliate Contact Lists on the GPV Teamsite and immediately inform Regional PV of any changes needed. Immediately inform all applicable License Partners concerning changes in the Affiliate PV staff.
· If required by local legislation, describe the Affiliate PV System (e.g. as DDPS, PSMF, PSSF etc., as applicable).
· Immediately inform the Regional PV Manager of any changes in the local PV regulations that might impact the global PV system.
· Keep the Local PV Requirements Inventory on the GPV Teamsite up to date and Immediately inform GPV on any changes in the local regulations that might affect the ICSR distribution.
· Immediately inform GPV for change in local products and about any new local contracts or license agreements which might require the exchange of safety data and Maintenance of (an) accurate local products list(s) to clearly show the product status as global or local. Immediately inform the GPV about any scheduled Audit or Inspection including business partner audits.
· Lead the PV audit/inspection process locally, with support from the relevant local or global functions.
· Train all Affiliate staff regarding “Basic PV” obligations.
· Upload all local PV Service Agreements in the Affiliate PV Service Agreements Inventory, on the GPV Teamsite.
· Upload all locally prepared periodic safety reports in the Local PSUR Inventory on the GPV Teamsite.
· PV business continuity planning and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance.
· Record retention (archiving). Ensures Pharmacovigilance documents are archived as per GPV policy Monitoring of Affiliate PV system performance and compliance, and resolving of nonconformities
· Ensures a local tracking system is in place, to ensure timely submissions of adverse events to Abbott Global Pharmacovigilance (GPV), and of Individual Case Safety Reports (ICSRs) and Periodic Reports for submission to the Regulatory Authority.
· Reports monthly compliance metrics to Global Pharmacovigilance (GPV) within the required timelines
· Completes monthly ICSR reconciliation with interacting departments and/or partner companies (if applicable) and acts upon any discrepancies
· Informs Local regulatory affairs for label updates as per information received from GPV.
Adverse event processing (Both local and global products):
· Ensures that local processes, procedures and systems are in place for receipt, recording, processing, translating (if required), quality checks, forwarding to GPV, tracking, follow-up and archiving of adverse events from spontaneous and solicited sources and Serous Adverse Events (SAEs) from clinical studies (where applicable), including pregnancy, overdose, misuse, abuse, medication errors or product quality complaint reports (in association with QA).
· Ensures local language medical or scientific literature, not included in GPV global literature review, social media (if applicable) are reviewed to identify possible adverse events, and that any reports are forwarded in a timely manner to GPV.
· Submission to health authorities as applicable.
· Ensure Product complaints are classified and shared to Quality Assurance (QA) team and GPV as appropriate.
· Ensures product complaints received by affiliate are reviewed for adverse events, and forwards any AEs identified to GPV
· As per local SOPs, ensure to completes reconciliation between QA and PV at the Affiliate, ensuring that all ICSRs have been identified
Periodic Safety Reports (Both local and global products):
· Provide accurate information for the global Periodic Safety Update Report (PSUR) schedule
· Maintain local PSUR schedule tracker
· Prepare periodic safety reports for local products
· Co-ordinates with GPV for review and submission of periodic safety reports for global products
· Forward any periodic safety report assessment report received from Health Authority
Scientific Literature Screening:
· Ensures local language medical or scientific literature, not included in GPV global literature review are screened and reviewed to identify possible adverse events, and that any reports are forwarded in a timely manner to GPV
Safety Data Exchange Agreements (SDEA)
· Ensure Implementation and maintenance of local SDEA
· Ensures content of local agreements is in line with Abbott standards
· Maintains compliance with local agreements, including reconciliation between partner companies.
· Ensure the content of local SDEA conforms to Abbott standards and local requirements.
· Submits all local SDEAs to GPV for approval prior to finalisation.
· Inform partner companies of changes in the Affiliate PV staff
· Ensures a local tracking system is in place, to monitor compliance to local safety data exchange agreement timeframes.
Social Media (Both local and global products):
· Ensures local language social media (if applicable) are screened and reviewed to identify possible adverse events, and that any reports are forwarded in a timely manner to GPV.
· Maintains a version-controlled training matrix for local PV personnel
· Ensures training of affiliate personnel on relevant PV responsibilities is undertaken on at least an annual basis, and that appropriate training records are maintained.
· Ensures that any training of partner company staff is completed according to local contract requirements, and appropriately documented.
· Training of new PV staff in affiliate
Audits and Inspections
· Acts as the key Affiliate contact for both internal audits and Regulatory Authority inspections.
· Ensures that any Regulatory Authority communications are forwarded to the required GPV personnel and that any corrective actions are completed according to schedule.
· Acts as a POC for the PSP/MRP vendor audits. Ensure CAPA Completion
Risk management (RM)
· If applicable, local implementation and tracking of RMP activities resulting from Global RMPs.
· Identify if a product requires RMP and share it with GPV in case of a requirement
· Monitors the risk/benefit profile of local products and communicates changes or concerns to GPV for evaluation
· For product safety queries for global products If any safety query received from HA, inform GPV of the same while for local product as required by the local regulation.
· Liaise with GPV for due diligence related activities
After Hours Availability
· Ensures that an afterhours process is in place and tested (e.g., to respond to Regulatory Authority questions and for emergency un-blinding of treatment codes for Abbott sponsored studies).
· Maintains up- to-date information on local Regulatory Authority out of hours contacts
Clinical Trials (Interventional/Non-interventional Studies/Programs):
· Ensure Compliance of affiliate driven studies with PV requirements
· Review of protocol, CSR, agreements for affiliate driven studies with vendors if needed Collection of safety data and other PV related responsibilities for local studies
· For local BE studies conducted for global products, perform the PV responsibilities
Thailand > Bangkok : Lumpini Building
Yes, 75 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)