Affiliate Safety Manager Germany (Stufenplanbeauftragte/r & Informationsbeauftragte/r)


Munich, BY, DE


Job Responsibilities
Following the recent opening of our German affiliate, we are now looking for an experienced, proactive, and team-oriented Associate Director, Affiliate Safety (Stufenplanbeauftragte/r & Informationsbeauftragte/r) in Munich.
The successful candidate needs to demonstrate great flexibility in dealing with a wide range of activities and is comfortable working in a fast-paced environment autonomously with minimal guidance.

Main responsibilities include:
The Affiliate Safety Manager (ASM)/ National Qualified Person for Pharmacovigilance (QPPV) and “Informationsbeauftragte/r”is a nominated contact person for PV primarily responsible for ensuring that local post-marketing PV activities are managed in compliance with national PV regulations, global and local company policies and procedures.


This role assumes the responsibilities to fulfil safety requirements on marketed Idorsia products in accordance with national legislation as follows:

PV systems and processes
•    Ensure that local systems and processes are established for the collection, tracking, review, translation (as applicable) and follow-up of Post-marketing Adverse Events (AEs), special reporting situations (medication error, overdose, abuse, misuse, etc.), 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.
•    Conduct reconciliation of adverse events for local late phase initiatives e.g. non-interventional studies, registries, patient support programs, etc. conducted by the affiliate; ensure procedure is in place for reconciliation of AEs received from external (3rd parties) or internal sources for solicited programs; conduct local reconciliation of adverse events, technical product complaints and medical information inquiries.
•    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.
•    Screen and report to GDS relevant local scientific and medical literature published AE case reports involving marketed Idorsia products.
•    Ensure business continuity at local level and that a Deputy ASM/ Deputy National QPPV is nominated to cover PV tasks during absence.


Health Authority communication, PV Inspections
•    Acts as the contact person to national Health Authorities (HAs) as required by local PV regulations.
•    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).
•    Notify the Head of Global Drug Safety (GDS), the EU QPPV, and Global Drug Regulatory Affairs (DRA) of any request received from local Health Authorities (HA) related to the safety of marketed Idorsia products.
•    Respond to questions from national Health Authorities in close coordination with GDS, EU QPPV and Global DRA.
•    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 Drug Safety Compliance Manager and EU QPPV and ensure timely implementation and compliance on new requirements.
•    Notify any change in the ASM / Local QPPV or deputy role to GDS, EU QPPV, and local Health Authorities (as applicable).


PV Training
•    Provide adequate, timely and documented training on drug safety reporting responsibilities to all Affiliate personnel and third parties providing PV relevant services; coordinate with the Affiliate Medical and Commercial departments the training of all affiliate personnel on AE reporting obligation and relevant staff members (including the General Manager, Sales Representatives, Medical Science Liaisons, Marketing department employees, etc.) on Risk Management Plan and Risk Minimization Measures for Idorsia marketed products.


Management of PV relevant vendors
•    Ensure that all safety-related third-party agreements (i.e., local handling of adverse events, patient support programs, market research programs, local literature screening, distributors, medical information services, receptionists/call centers, etc.) include the appropriate Pharmacovigilance language incorporated and is aligned with the global PV template/s.
•    Ensure oversight of PV activities outsourced to third parties.


Quality Assurance
•    Monitor and ensure implementation of appropriate Corrective Action Preventive Action (CAPA) identified during PV audits and inspections.
•    Capture and document self-identified local PV deviations and implement CAPAs.

Pharmacovigilance System Master File (PSMF)
•    Provide accurate and timely input into the PSMF on relevant local PV information as requested by the EU QPPV.




Candidate’s Requirements
•    University Degree, preferably in Medicine, Pharmacy, Life-Sciences or Nursing.
•    Previous experience in the pharmaceutical industry in drug safety and/or related functions.
•    Strong knowledge of local pharmacovigilance (PV) requirements and global aspects of Drug Safety.
•    Informationsbeauftragter qualification or relevant experience.
•    Excellent verbal and written communication skills to communicate with health authorities and external organizations.
•    Fluent in English and German.
•    Computer literate with knowledge of relevant IT safety systems.
•    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.
•    Excellent organizational and problems solving skills, interpersonal skills and the ability to work under pressure and meet tight timelines.

What Idorsia offers
•    Exciting opportunities  for development and professional growth within our dynamic organization
•    A collaborative and solution oriented enviroment where you can make a difference
•    An innovative and open culture in a truly multicultural environment
•    A competitive salary and benefits

Work  Location: Munich
Country: Germany
Business Area: Commercial Operations  - EUCAN Region
Schedule: Fulltime 
Job Type: Permanent