Medical Device und Pharmacovigilance Manager

Medical Device und Pharmacovigilance Manager

Sobi

Munich, Germany

Job Description

The Manager, Pharmacovigilance & Medical Device Compliance is primarily responsible for establishing, maintaining, and continuously developing the company's pharmacovigilance system. In addition, the role is responsible for ensuring compliance with regulatory requirements for medical devices and serves as the interface between pharmaceutical and medical device regulations.

Job responsibilities include, but are not limited to

Pharmacovigilance (approx. 60%)

• Managing and contributing to all pharmacovigilance (PV) activities
• Maintaining and continuously improving a pharmacovigilance system
• Supporting inspections by national regulatory authorities and providing the necessary support for global pharmacovigilance activities and other regulatory inspections
• Establishing processes to ensure pharmacovigilance compliance, including documentation
• Creating and maintaining PV SOPs and templates
• Ensuring colleagues are trained on local and global SOPs and procedures
• Performing reconciliation (line listing) of AE/SAE cases and complaints at the local level in accordance with Sobi AB/Akcea requirements; reviewing monthly ICSR compliance reports and preparing the local periodic check of Pharmalex performance
• Reviewing potential late cases from ESPs and Sobi employees
• Archiving, processing, and locally documenting all product complaints, as well as maintaining reconciliation lists (line listings) for AE/SAE cases
• Collecting, processing, and reporting all drug safety information within the affiliate and to Sobi headquarters, including performing translations and quality checks of safety information as required
• Coordinating requests for follow-up information related to all complaints
• Training all colleagues/ESPs on pharmacovigilance
• Overseeing and implementing pharmacovigilance requirements in third-party partner agreements, including distributors, medical information, clinical development, patient support programs, market research activities, social media, and other digital media activities
• Documenting and managing PV-related deviations and CAPAs

Medical Devices (approx. 40%)

• Acting as the person responsible for medical device safety in accordance with §6 MPBetreibV (German Medical Devices Operator Ordinance)
• Supporting regulatory matters related to medical devices in accordance with the MDR (Medical Device Regulation) and MPBetreibV
• Responsibility for vigilance processes for medical devices
• Creating, continuously updating, and reviewing relevant SOPs
• Monitoring regulatory changes in medical device legislation
• Collaborating with external notified bodies and authorities as required
• Reviewing medical devices

Qualifications

• Completed degree in pharmacy, medicine, natural sciences, or a comparable field of study
• 3-5 years of professional experience in pharmacovigilance
• Strong knowledge of EU Good Pharmacovigilance Practice (EU-GVP) requirements
• Knowledge of the MDR/MPBetreibV and medical device vigilance is an advantage