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Drug Safety Manager (m/f/d) (EN)

[11861]
Drug Safety / Pharmacovigilance, Swissmedic, PV & QA Erfahrung

Job title: Drug Safety Manager 50% (m/f/d) Industry: Pharma Skills: Drug Safety / Pharmacovigilance,Swissmedic,PV & QA Erfahrung Start of project: 01.09.2022 Duration of the project : 12 months Project volume: 50% Location: Switzerland - Hybrid Tasks: • Responsible for executing procedures to ensure compliance with both local and regional PV regulations and company global and regional policies and procedures. • Responsible for executing of assigned PV tasks in absence of PV Affiliate Lead. • Management of Product Safety Information (PSI): ensures that safety information (Adverse Events) received by the affiliate from all sources are  collected, translated and forwarded to designated Global PV Headquarter, in compliance with required timelines (reporting timelines), quality guidelines and standards. • Performs case intake, data entry and review of case reports in the PSI Intake and Triage Application • Performs follow up activities for ICSRs, as required • Performs local Health Authority ICSR submissions, as required • Responsible for filing, storage and archiving of case documentation in the PSI Intake and Triage Application and/or electronic archive, as applicable • Supports reconciliation activities of PSI Intake and Triage Application with other company operating unit systems (e.g. Medical Information and Quality Assurance) and contractual partners/vendors, as applicable • Supports the implementation of relevant updates to PV regulations, communicates any changes to the respective company functions • Provides input for the PSMF regarding the affiliate communication to global PV • Supports in ensuring the affiliate is GVP inspection-ready, provides support in regulatory authority inspections, business partner or internal audits. • Supports testing of PV systems and communication channels • Supports the review of contracts with vendors and License Partners • Supports the development and maintenance of locally applicable PV Quality documents. • Ensures filing, storage and archiving of PV documentation in accordance with PV regulations and with company policies and procedures • Contributes to the oversight and monitoring of all local studies and projects, including digital media, marketing initiatives and company-sponsored websites that impact PV • Participates in local activities concerning Risk Management Plans and Risk Minimization Measures and supports the implementation activities. • Responsible for effective collaborations and communications with: PV HQ functions, PV Affiliate Operations, Affiliate M&D and non-M&D functions • Provides PV Trainings (onboarding/refreshers) to the affiliate or vendor staff, ensures the training documentation is in place Qualifications: • Minimum BA/BS (Pharmacy, Medical or Biomedical/Life Sciences preferred) preferably with an advanced professional degree • Demonstrated and relevant minimum 1-2 years of experience within PV and/or combined PV/RA/QA; direct contact and engagement with national competent authorities preferred • Good understanding of establishing and maintaining (GxP) Quality Management Systems. • Awareness of local industry code(s) of practice and local and/or regional PV regulations and guidelines. (Swissmedic) • Experience in supporting a PV system in at least one single country; low complexity, low case volume. • Case Processing experience strongly preferred: experience with Data Entry and Submissions, databases: ARISg or LSIT/LSMV experience preferred • Awareness and experience with some aspects of a PV quality management system • Proficiency in local languages: German is a must, French and Italian are a plus. Business English language (written, verbal, presentation, facilitation) is a must.

Job title: Drug Safety Manager 50% (m/f/d)
Industry: Pharma
Skills: Drug Safety / Pharmacovigilance,Swissmedic,PV & QA Erfahrung
Start of project: 01.09.2022
Duration of the project : 12 months
Project volume: 50%
Location: Switzerland - Hybrid

Tasks:

• Responsible for executing procedures to ensure compliance with both local and regional PV regulations and company global and regional policies and procedures.
• Responsible for executing of assigned PV tasks in absence of PV Affiliate Lead.
• Management of Product Safety Information (PSI): ensures that safety information (Adverse Events) received by the affiliate from all sources are  collected, translated and forwarded to designated Global PV Headquarter, in compliance with required timelines (reporting timelines), quality guidelines and standards.
• Performs case intake, data entry and review of case reports in the PSI Intake and Triage Application
• Performs follow up activities for ICSRs, as required
• Performs local Health Authority ICSR submissions, as required
• Responsible for filing, storage and archiving of case documentation in the PSI Intake and Triage Application and/or electronic archive, as applicable
• Supports reconciliation activities of PSI Intake and Triage Application with other company operating unit systems (e.g. Medical Information and Quality Assurance) and contractual partners/vendors, as applicable
• Supports the implementation of relevant updates to PV regulations, communicates any changes to the respective company functions
• Provides input for the PSMF regarding the affiliate communication to global PV
• Supports in ensuring the affiliate is GVP inspection-ready, provides support in regulatory authority inspections, business partner or internal audits.
• Supports testing of PV systems and communication channels
• Supports the review of contracts with vendors and License Partners
• Supports the development and maintenance of locally applicable PV Quality documents.
• Ensures filing, storage and archiving of PV documentation in accordance with PV regulations and with company policies and procedures
• Contributes to the oversight and monitoring of all local studies and projects, including digital media, marketing initiatives and company-sponsored websites that impact PV
• Participates in local activities concerning Risk Management Plans and Risk Minimization Measures and supports the implementation activities.
• Responsible for effective collaborations and communications with: PV HQ functions, PV Affiliate Operations, Affiliate M&D and non-M&D functions
• Provides PV Trainings (onboarding/refreshers) to the affiliate or vendor staff, ensures the training documentation is in place


Qualifications:

• Minimum BA/BS (Pharmacy, Medical or Biomedical/Life Sciences preferred) preferably with an advanced professional degree
• Demonstrated and relevant minimum 1-2 years of experience within PV and/or combined PV/RA/QA; direct contact and engagement with national competent authorities preferred
• Good understanding of establishing and maintaining (GxP) Quality Management Systems.
• Awareness of local industry code(s) of practice and local and/or regional PV regulations and guidelines. (Swissmedic)
• Experience in supporting a PV system in at least one single country; low complexity, low case volume.
• Case Processing experience strongly preferred: experience with Data Entry and Submissions, databases: ARISg or LSIT/LSMV experience preferred
• Awareness and experience with some aspects of a PV quality management system
• Proficiency in local languages: German is a must, French and Italian are a plus. Business English language (written, verbal, presentation, facilitation) is a must.


map Schweiz date_range 01.09.2022 update Temporary
Direct contact

Moritz Janssen

Recruitment Consultant
mail m.janssen@aristo-group.ch
phone +41 44 274 39 00


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