To support management of pharmacovigilance (PV) processes at Country(ies) / Territory(ies) level in ensuring compliance with company global / local procedures, national and international regulations / standards / guidelines for pharmacovigilance (drug and device marketed and investigational products (drug and devices).
The Local Safety Officer (LSO) may act as the person responsible for PV (national Qualified Person for Pharmacovigilance (QPPV)) / deputy, where required.
The LSO ensures performance of Local PV system in their assigned Country(ies) / Territory(ies) as per with local regulatory and global company requirement
Acts as a pharmacovigilance single contact point for country / territory Health Authority on a 24 Hour basis if required or as per local requirement, including ensuring that adequate systems for out of hour’s coverage are in place.
Performs and manages collection, documentation, triage, translation (if applicable) processing in Safety Database, transferring to global processing sites (if applicable), follow-up, submission / distribution to local health authorities or ethic committees (if applicable) and archiving of all safety reportsfor all products (drugs and devices) from pre and post-authorization phase (when applicable) according to the defined timelines in company procedures.
Performs timely monitoring of PV regulation in their assigned Country(ies) / Territory(ies) and inform appropriate functions
Performs reconciliation of Individual Case Safety Reports (ICSRs) with appropriate internal and external stakeholders are performed in timely manner and in compliance with company procedures.
Supports development, implementation and ensures compliance of local PV procedures such as Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidelines, escalating any deviation from procedure where required.
Performs the timely submissions of safety reports (ICSRs, aggregate reports) to local Health Authority including identification of root cause(s) for late reporting to local Health Authority, development and implementation of Corrective and Preventive Action (CAPAs) as needed.
Ensures complianceto SOPs / WIs and escalate deviations from procedure
Manages and performs local PV activities are adequately covered during / after business hours and documented in the local Business Continuity Plans
Ensures compliance with regulations and guidelines; escalating issues impacting global PV processes or potentially impacting other functions at Syneos Health / Sponsor
Supports / Develops training materials for pharmacovigilance and conducts PV training relevant internal and external stakeholders, if applicable.
Performs activities and deliverables related to market research, patient assistance and other organized data collection programs as per set procedures.
Liaise with program owners to ensure appropriate mechanisms to collect, report, manage and reconcile safety information as well as appropriate adverse event training to the involved stakeholders.
Performs local literature search and social media are performed in timely manner.
Performs timely completion of activities related to PV Agreements (PVAs) and other agreements involving PV.
Supports in audits preparation, inspection preparation, Quality Investigations, CAPA plans and implementation when related to LSOs within Country (ies) / Territory (ies).
Supports PV Management to ensure that compliance investigations are conducted and completed according to timelines.
Coaches the Country (ies) / Territory(ies) PV staff towards achieving the globally set standard
Maintains accurate KPI and provides to the PV Management / appropriate function in a timely manner.
Work with local / global / external teams in developing and implementing local Risk Management Plans (RMPs) and support the PV Management / appropriate function as applicable.
Manage and contribute to RMP commitment status tracking activities, including : Coordination and Monitoring of local implementation of RMP commitments and training.
Supports the local QPPV in the timely and compliant execution locally of the Pharmacovigilance activities, if applicable
Degree (Bachelors / Masters) in medicine, pharmacy or life-science related discipline (e.g. MD, pharmacist, or life scientist / biologist) preferred or equivalent combination of education and experience
Extensive experience within Medical Device area & Device Vigilance
Demonstrate expert knowledge of pharmacovigilance legislation, skilled in all aspects of pharmacovigilance;
Minimum of five (5) years broad experience within Safety and Pharmacovigilance including operational case handling, data entry, medical review, signal detection, surveillance activities and quality.
Significant experience in the Pharmaceutical Industry required, including relevant PV experience and more broadly exposure to pharmaceutical development.
Familiar with building, correcting and maintaining local PV systems.
Exposure to and knowledge of Pharmacovigilance System Master File (PSMF), Safety Data Exchange Agreements (SDEAs), Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs) and other QPPV related activities.
Knowledge and understanding of pharmacological and medical terminology.
Development and / or implementation of process improvement initiatives.
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management / shared content / workspace), and internet.
Business level proficiency in English and local language.
Strong interpersonal and presentation skills; exhibits professional maturity, confidence, and competence. Knows how to summarize and communicate the key points and business case for others to effectively and expeditiously make important decisions.
Excellent organisational skills and sense of urgency / working to tight timelines.
Structured with a high attention to details.
Demonstrated ownership of projects and tasks.
Have a flexible approach.
Minimal travel required.