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About Our Client
Our client is a major pharmaceutical company.
Toobtain and maintainthoroughknowledgeofcompanyprocedures and legalrequirementsregarding
- Pharmacovigilance, as well as having a good knowledge of the PV aspects of the company portfolio.
- Handling of Individual Case Safety Reports according to local legislation and company QDs.
- Providing relevant safety information to HA, internal stakeholders and external parties. Ensure involvement of GPE, GSO and CSL as appropriate.
- Upon agreement support the CSL in local safety surveillance activities, safety issues, risk management activities, product alerts, patient support programs and market research programs throughout the affiliate. Inform GPE and HA about safety issues in accordance with local legislation and company QDs.
- Participate in writing and updating of local QDs according to corporate QDs and local legislation.
- Training of employees in PV relevant processes applicable for their function.
- Collaborate with applicable third parties within PV area.
- Actively support corporate policies, values and initiatives.
- To deputize for the country safety lead when appropriate.
In conjunctionwiththeCSLtoorganize a PVQualitysystemensuringthat :
- Processes are compliant with local PV regulations and the global group procedures are implemented, documented and followed locally. Accountable for keeping Global GPE via Regional Safety Lead aware of any future changes in local PV regulations. Development and maintenance of the local PV System Master File in accordance with the global standards.
Implements and reviews processes / Quality Documents to comply with local PV regulations and global group procedures.
- Education and training on safetytopicswithinthe local organization are performed service providers and manufacturing sites). including documentation ofattendees and topicscovered (i.e.: PVAwareness, training of
- Management of local compliance metrics generation, Root Cause Analysis (RCA) & Corrective Actions Preventive Actions (CAPAs) implementation and related tracking activities (ICSRs/ PSRs/ HA queries).
- Monitors the implementation of the PV requirements for local activities around PSP/MR Programs and digital medias.
- Responsible of the oversight of its local PV activities through completion of periodic reports (e.g. PV Activity Report) and providing this oversight to the RSL and GPE.
- Ensures timely completion of audit and inspection observations in close interaction with
- Global /Local Functions.
- Ensuring inspection readiness of the local PV system (auditable trail of all PV activities performed locally is maintained and readily available).
In conjunction with the CSL to organize a PV Operating system ensuring that :
PV data is timely reported to the PV unit and handled appropriately. Continuously monitor and review incoming calls, mails to identify ICSRs and other safety information needing reporting to GPE, HAs and partners if applicable. Ensuring case documentation completeness by appropriate communication with HCP and with consumers.
Procedures relating to the interface with local functions such as Medical Information, Medical, Clinical Study Unit, Marketing, Quality, Marketing (e.g. monitoring of social media, Customer Services, Training, etc.) are in place to guarantee the timely detection and transmission of PV data to the local PV unit.
In conjunction with the CSL to organize a Safety Management System ensuring that:
- All safety-related questions raised by local Health Authorities are collated and immediately transmitted by e-mail to the GSO of the concerned GPE Business Unit and to the relevant GPE mailbox for evaluation and organization for further immediate communication within GPE and action as relevant. Local sponsored websites/social media are monitored as defined by the social media guidelines.
The process for local safety surveillance activities is defined and such activities are performed.
Supports the GSO with local safety surveillance activities.
- Productsafetyalerts are handled in accordancewithcompanyproductalertprocesses. Local PVAlerts are managed and coordinated in collaboration withGPE, the relevant medicaldirector and local Management.
The Successful Applicant
- At least 3 years of experience in the pharmaceutical industry and in Pharmacovigilance.
- Experience working in an international company with complex organizational environment.
- Fluent in English, Good level in German and French.
- Autonomous and team player.
- Strong organizational skills.
- Excellent interpersonal and communication skills.
- High sense of prioritization.
What's on Offer