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Drug Safety Specialist (m/f/d) (DE)
[5960]
Our client is a biopharmaceutical company specializing in the research, development and marketing of drugs in the fields of immunology and the central nervous system. As soon as possible we are looking for a committed Drug Safety Specialist (m/f/d) In temporary employment, part-time for 20h/week Your tasks Pharmacovigilance System: ·Maintain a functional connection with the EEA Qualified Person for Pharmacovigilance (QPPV) e.g . participating in regular LSO meetings organized by corporate Patient Safety; ·In collaboration with the Safety Leader for DACH and the GPO maintain the pharmacovigilance system for products authorized in the territory and ensure compliance with applicable regulatory and company requirements; ·Work in close collaboration with the corporate Patient Safety team to ensure that local obligation is managed and compliance to local authorities is maintained; ·Provide input into global/local processes to ensure compliance; ·Maintain quality management system related to the pharmacovigilance, including management of Standard Operating Procedures (SOPs), Associated Instructions (Ais), and documents (e.g. forms, templates) to describe local processes and requirements and perform regular gap analysis as needed on order to ensure alignment with global SOPs; ·Maintain oversight of the local deliverables delegated to service providers; ·Ensure timely management of deviations and risk mitigation by defining appropriate CAPAs and ongoing trend analysis as appropriate. Safety Communication: ·Perform triage of the generic email inboxes and the patient safety phone on regular basis; ·Knowledge of product safety risks to act proactively and independently with local and global stakeholders and proactively escalate local safety issues to the Safety Leads as appropriate; ·Champion the coordination and enable effective safety communication to HA/HCPs and patients and ensure appropriate follow-up; ·Maintain Quality Checks (QCs) of stakeholders involved in Adverse Event (AE) Case processing and literature screening on regular basis. Pharmacovigilance Regulatory Intelligence: ·Maintain thorough knowledge of the local current pharmacovigilance regulatory requirements and landscape plus proactivelv monitor for emerqinq regulations and communicate such to corporateteamsand local stakeholders; ·Perform Impact assessment, gap analysis and implementation strategy for new or updated regulations and notify the EEA QPPV, corporate Patent Safety and relevant stakeholders. ·Health Authority inspection and Audit readiness: ·Ensure inspection and audit readiness of the relevant local departments in full collaboration with corporate Patient Safety and Quality Assurance; ·Participate in and manage pharmacovigilance audits and inspections, perform root cause analysis, ensuring timely identification and implementation or respective Corrective Actionsand Preventive Actions (CAPAs). Product Stewardship: ·Ensure that all information relevant to the benefit/risk balance of the or client's products is reported to patient safety (including the EEA QPPV for products authorized in the EEA) for further review and to the competent authorities according to the local pharmacovigilance legislation; ·Provide input to the Risk Management Strategy as needed to secure local compliance; ·Act as local Subject Matter Expert on product safety, contributing to the product lifecycle activities, product information (e.g. labelling review) and risk management e.g. recalls, DHCP letters, implementation of Risk Managements Plans as applicable . Partnership Management: ·Engage in transversal collaboration with affiliate and corporate stakeholders to secure pharmacovigilance compliance; ·Maintain overview and update of pharmacovigilance service contracts and associated documentation of contracted vendors for territory. Pharmacovigilance Training: ·Ensure that staff managing safety activities for or on behalf of the affiliate have the appropriate qualification and training; ·Ensure that a pharmacovigilance training is provided to any local employees and applicable Vendors as applicable. Your qualifications ·Bachelor's Degree in natural sciences; ·3-5 years in Pharmacovigilance at minimum; ·Scientific background in Central Nervous System and/or immunology therapeutic areas helpful ·Expert in pharmacovigilance, with an in-depth expert knowledge of associated regulatory requirements applicable in the DACH territories; ·Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives in order to aim for 100% compliance; ·Have strong interpersonal skills, especially in the area of individual leadership and adaptability; ·Team working and networking promoter; ·Excellent oral and written communication in German and English. You will be offered ·30 days vacation ·Capital-forming benefits ·Overtime regulation ·Christmas and vacation bonus ·Work-life balance ·Working in a modern working environment ·Fast and professional training and ·Personal support from the beginning of the application process If you feel attracted by this job feel free to get in touch with Bettina Cöppicus at Optares via bettina.coeppicus@optares.de or by phone under +49 441 21879-18
Pharmacovigilance System:
- Maintain a functional connection with the EEA Qualified Person for Pharmacovigilance (QPPV) e.g . participating in regular LSO meetings organized by corporate Patient Safety;
- In collaboration with the Safety Leader for DACH and the GPO maintain the pharmacovigilance system for products authorized in the territory and ensure compliance with applicable regulatory and company requirements;
- Work in close collaboration with the corporate Patient Safety team to ensure that local obligation is managed and compliance to local authorities is maintained;
- Provide input into global/local processes to ensure compliance;
- Maintain quality management system related to the pharmacovigilance, including management of Standard Operating Procedures (SOPs), Associated Instructions (Ais), and documents (e.g. forms, templates) to describe local processes and requirements and perform regular gap analysis as needed on order to ensure alignment with global SOPs;
- Maintain oversight of the local deliverables delegated to service providers;
- Ensure timely management of deviations and risk mitigation by defining appropriate CAPAs and ongoing trend analysis as appropriate.
Safety Communication:
- Perform triage of the generic email inboxes and the patient safety phone on regular basis;
- Knowledge of product safety risks to act proactively and independently with local and global stakeholders and proactively escalate local safety issues to the Safety Leads as appropriate;
- Champion the coordination and enable effective safety communication to HA/HCPs and patients and ensure appropriate follow-up;
- Maintain Quality Checks (QCs) of stakeholders involved in Adverse Event (AE) Case processing and literature screening on regular basis.
Pharmacovigilance Regulatory Intelligence:
- Maintain thorough knowledge of the local current pharmacovigilance regulatory requirements and landscape plus proactivelv monitor for emerqinq regulations and communicate such to corporateteamsand local stakeholders;
- Perform Impact assessment, gap analysis and implementation strategy for new or updated regulations and notify the EEA QPPV, corporate Patent Safety and relevant stakeholders.
- Health Authority inspection and Audit readiness:
- Ensure inspection and audit readiness of the relevant local departments in full collaboration with corporate Patient Safety and Quality Assurance;
- Participate in and manage pharmacovigilance audits and inspections, perform root cause analysis, ensuring timely identification and implementation or respective Corrective Actionsand Preventive Actions (CAPAs).
Product Stewardship:
- Ensure that all information relevant to the benefit/risk balance of the or client's products is reported to patient safety (including the EEA QPPV for products authorized in the EEA) for further review and to the competent authorities according to the local pharmacovigilance legislation;
- Provide input to the Risk Management Strategy as needed to secure local compliance;
- Act as local Subject Matter Expert on product safety, contributing to the product lifecycle activities, product information (e.g. labelling review) and risk management e.g. recalls, DHCP letters, implementation of Risk Managements Plans as applicable .
Partnership Management:
- Engage in transversal collaboration with affiliate and corporate stakeholders to secure pharmacovigilance compliance;
- Maintain overview and update of pharmacovigilance service contracts and associated documentation of contracted vendors for territory.
Pharmacovigilance Training:
- Ensure that staff managing safety activities for or on behalf of the affiliate have the appropriate qualification and training;
- Ensure that a pharmacovigilance training is provided to any local employees and applicable Vendors as applicable.
Your qualifications
- Bachelor's Degree in natural sciences;
- 3-5 years in Pharmacovigilance at minimum;
- Scientific background in Central Nervous System and/or immunology therapeutic areas helpful
- Expert in pharmacovigilance, with an in-depth expert knowledge of associated regulatory requirements applicable in the DACH territories;
- Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives in order to aim for 100% compliance;
- Have strong interpersonal skills, especially in the area of individual leadership and adaptability;
- Team working and networking promoter;
- Excellent oral and written communication in German and English.
You will be offered
- 30 days vacation
- Capital-forming benefits
- Overtime regulation
- Christmas and vacation bonus
- Work-life balance
- Working in a modern working environment
- Fast and professional training and
- Personal support from the beginning of the application process
If you feel attracted by this job feel free to get in touch with Bettina Cöppicus at Optares via bettina.coeppicus@optares.de or by phone under +49 441 21879-18
Bettina Cöppicus