Affiliate Drug Safety Manager DACH (m/f/d)
Location:
München, BY, DE
We would love to welcome you in our team in Munich / Germany as
Affiliate Drug Safety Manager DACH (m/f/d)(full-time; permanent)
About Idorsia
The purpose of Idorsia is to discover, develop and bring more innovative medicines to patients. We have more ideas; we see more opportunities and we want to help more patients. In order to achieve this, we would like to develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.
Idorsia is headquartered in Switzerland and has already established commercial operations in the US, Canada and major strategic locations in Europe.
With the commercial operations for the DACH region based in Munich, we are helping to realize Idorsia’s ambition of bringing innovative medicines from bench to bedside.
Job Profile
The Affiliate Drug Safety Manager DACH (m/f/d) is a nominated contact person for Pharmacovigilance (PV) primarily responsible for ensuring that local post-marketing PV activities in the DACH region are managed in compliance with national PV regulations, global and local company policies and procedures.
The Affiliate Safety Manager will also act as (deputy) “Stufenplanbeauftragte/r” in Germany.
This role assumes the responsibilities to fulfil safety requirements on marketed Idorsia products in accordance with national legislation as follows:
Pharmacovigilance systems and processes
1. Ensure that local systems and processes are established and conducted for the collection, tracking, review, translation (as applicable) and follow-up of Post-marketing Safety Information, and Product Quality Complaints (PQC) received from all sources: spontaneous, solicited AEs from local programs (e.g. registries, patient support programs, market research etc..), local health authorities, and other potential sources including reconciliation
2. Collaborate with EU QPPV, global and local departments to ensure oversight of post-marketing safety data generating activities and SAEs reported from post-marketing clinical trials.
3. Screen and report to Global Drug Safety relevant local scientific and medical literature published AE case reports involving marketed Idorsia products.
4. Ensure business continuity at local level and that a Deputy Affiliate Safety Manager is nominated to cover PV tasks during absence.
Health Authority communication, Pharmacovigilance Inspections
5. Acts as the contact person to national Health Authorities (HAs) as required by local PV regulations.
6. Ensure PV inspection readiness and acts as the Lead for the management of national PV audits and HA PV inspections in close collaboration with Idorsia Quality Assurance (QA) and European Qualified Person responsible for Pharmacovigilance (EU QPPV).
7. Monitor changes in regulations which may impact PV activities, evaluate impact on local processes and communicate promptly any changes in local PV legislation to GDS
8. Notify any change in the Affiliate Drug Safety Manager / Local QPPV or deputy role to GDS, EU QPPV, and local Health Authorities (as applicable).
Pharmacovigilance Training
9. Coordinate and provide adequate, timely and documented training on drug safety reporting responsibilities to all Affiliate personnel and third parties providing PV relevant services; as well as training on PV processes, Risk Management Plans or other PV related trainings to relevant staff members.
Management of Pharmacovigilance relevant vendors
10. Ensure that all pharmacovigilance-related third-party agreements include the appropriate Pharmacovigilance language incorporated and is aligned with the global PV template/s.
11. Ensure oversight of PV activities outsourced to third parties.
Quality Assurance
12. Monitor and ensure implementation of appropriate Corrective Action, Preventive Action (CAPA) identified during PV audits and inspections.
13. Capture and document self-identified local PV deviations and implement CAPAs.
Pharmacovigilance System Master File (PSMF)
14. Provide accurate and timely input into the PSMF on relevant local PV information as requested by the EU QPPV.
Requirements
15. University degree in Medicine, Biology, Pharmacy, Chemistry or other related disciplines
16. At least 7 years of professional experience in the pharmaceutical industry in drug safety and/or related functions.
17. Strong knowledge of local Pharmacovigilance requirements and global aspects of Drug Safety.
18. Excellent verbal and written communication skills to communicate with health authorities and external organizations.
19. Fluent in German and English languages.
20. Computer literate with knowledge of relevant IT safety systems.
21. Experience with collection and reporting of post-marketing Adverse Drug Reactions/Adverse Events (ADRs/AEs) as well as Serious Adverse Events (SAEs) from clinical trials.
22. Excellent organizational and problems solving skills, interpersonal skills and the ability to work under pressure and meet tight timelines.
Idorsia values
Next to your personal requirements you should be also familiar with the Idorsia values:
Advance: To achieve our ambitious goals, we move forward with energy and vigour. We take full responsibility for finding solutions and outperforming the competition.
Pragmatic: Whatever the challenge, we are flexible and pragmatic in implementing initiatives without compromising the quality of our work.
Invent: To seize more opportunities, we are resourceful, creative, and imaginative. Our work is scientifically orientated, and data driven. We are open to novel approaches in all areas.
Team-up: We enjoy working as a team and use the power of our shared passion. We work collaboratively, share information and exchange ideas, listen to each other, and support each other.
Benefits
23. Exciting opportunities for development and professional growth within our dynamic organization.
24. A collaborative and solution-oriented environment where you can make a difference.
25. An innovative and open culture in a multicultural environment.
26. A competitive salary and a variety of additional benefits.
27. A state-of the art office in the heart of Munich with flexible home office options.
Work Location: Munich
Country: Germany
Business Area: Global Medical Affairs
Schedule: Fulltime
Job Type: Permanent