Aktuelle Jobs im Zusammenhang mit Drug Safety Manager - Munich, Bayern - Progressive

  • Drug Safety Specialist

    vor 1 Woche

    Munich, Bayern, Deutschland LMU Klinikum München Vollzeit

    Das LMU Klinikum ist eines der größten und leistungsfähigsten Universitätsklinika in Deutschland und Europa. 48 Fachkliniken, Abteilungen und Institute mit einer exzellenten Forschung und Lehre ermöglichen eine Patientenversorgung auf höchstem medizinischen Niveau. Hieran sind rund Mitarbeiterinnen und Mitarbeiter beteiligt.Ihr...

  • drug product manager

    vor 1 Woche

    Munich, Bayern, Deutschland Discover International Vollzeit

    ConsultantTechnology Management Drug ProductTasksAdvise teams for Site-Launch activities for internal and external sites (incl. lab units, SC, RACMC and QA)Communicate with internal and external sites as part of the projectReview technical documentation (protocols, reports) associated with manufacturing, tech transfer, site-to-site transfers and PPQ as...

  • Quality, Safety and Documentation Manager

    vor 1 Woche

    Munich, Bayern, Deutschland LI-COR Vollzeit

    Primary Work LocationBad HomburgOverviewQuality – Manage all aspects of Quality Assurance and Manufacturing Documentation for the Environmental (ENV) business unit.  Identify, design, develop, and maintain systems, equipment, and reference standards for the inspection and calibration of in-process subassemblies and finished goods.  Manage incoming part...

  • Safety Engineer

    vor 2 Wochen

    Munich, Bayern, Deutschland Stark Vollzeit

    About Us STARK is a new kind of defence technology company revolutionizing the way autonomous systems are deployed across multiple domains. We design, develop and manufacture high performance unmanned systems that are software-defined, mass-scalable, and cost effective. This provides our operators with a decisive edge in highly contested environments.We're...

  • Functional Safety Engineer

    vor 1 Woche

    Munich, Bayern, Deutschland Akkar Vollzeit

    This position is a cornerstone technical leadership role focused onchip-level functional safety. You'll develop and implement hardware safety strategies that meet ISO 26262, SOTIF, and ISO/SAE 21434 standards, ensuring that our SoCs, CPUs, and NPUs deliver uncompromising reliability for safety-critical applications.You'll also act as the technical lead in...

  • Functional Safety Engineer

    vor 1 Woche

    Munich, Bayern, Deutschland Monolithic Power Systems, Inc. Vollzeit

    Monolithic Power Systems, Inc. (MPS) is one of the fastest growing companies in the Semiconductor industry. We are worldwide technical leaders in Integrated Power Semiconductors and Systems Power delivery architectures. At MPS, we cultivate creativity, are passionate about sustainability, and are committed to provid...

  • Senior Manager Drug Substance

    Vor 3 Tagen

    Munich, Bayern, Deutschland Exyte Vollzeit

    DescriptionDiscover your exciting rolesExyte is a globally leading company in the design and realization of highly complex production facilities for the high-tech industry.Our clients from the pharmaceutical, biotechnology, and semiconductor sectors rely on our expertise in process engineering. To strengthen our leadership team, we are looking for an...

  • Functional Safety Engineer – ADAS/AD Software Stack

    Vor 3 Tagen

    Munich, Bayern, Deutschland Autobrains Technologies Vollzeit

    As a Functional Safety Engineer, you will be responsible for ensuring the development and integration of functional safety processes and requirements in alignment with ISO 26262 and ISO/PAS SOTIF) standards. You will support the safety lifecycle of complex automotive software components spanning the full ADAS/AD software stack, including embedded software...

  • Pharmacovigilance Specialist

    vor 1 Woche

    Munich, Bayern, Deutschland Progressive Vollzeit

    Have you already gained initial experience in Drug Safety or Pharmacovigilance, bring along knowledge in PV-reports from Rx-Logix and are now ready to take the next step with a leading biotechnology company? If so, you could be the ideal candidate for the following opportunity I am currently managing:Pharmacovigilance Associate (gn) - HomebasedYour...

  • Senior CMC Manager

    Vor 3 Tagen

    Munich, Bayern, Deutschland Barrington James Vollzeit

    The Senior CMC Manager will play a key leadership role in defining and delivering CMC strategy across the company's gene therapy pipeline. You will oversee internal and external activities spanning process development, GMP manufacturing, analytical development, and regulatory documentation. This position requires strong technical depth, exceptional...

Drug Safety Manager

vor 2 Wochen

Munich, Bayern, Deutschland Progressive Vollzeit

Drug Safety Manager (gn)

Location:
Munich |
Department:
Pharmacovigilance |
Start:
ASAP

Your Mission:
As a Local Safety Officer (LSO), you will play a key role in ensuring drug safety. You will guarantee compliance with local and global regulatory requirements and actively contribute to the continuous improvement of our European PV system.

Your Responsibilities:

Stay ahead of regulations:
Monitor local pharmacovigilance requirements assess their impact, and keep our global PV team informed.

Drive process excellence:
Support global PV initiatives and ensure smooth local implementation of new processes and standards.

Maintain compliance:
Update local procedures to align with regulatory changes and company policies.

Ensure accurate reporting:
Oversee vendors and manage the collection, translation, and submission of safety reports with precision and quality.

Collaborate effectively:
Work closely with internal teams and external partners to reconcile safety data and maintain transparent communication.

Monitor scientific literature:
Review local publications for potential adverse drug reactions related to our products.

Manage agreements:
Prepare and implement pharmacovigilance agreements with license partners and service providers.

Implement risk measures:
Execute additional risk minimization strategies and manage DHPC communications as required.

Support affiliate activities:
Advise on PV needs for local projects, studies, and partnerships to ensure compliance from the start.

Evaluate programs:
Assess patient support initiatives, market research, and digital projects for PV compliance.

Keep systems updated:
Provide accurate local data for the Pharmacovigilance System Master File (PSMF).

Track performance:
Generate KPIs and reports to keep stakeholders informed about PV activities.

Audit readiness:
Lead preparations for audits and inspections, manage CAPAs, and ensure timely resolution of deviations.

Your Profile:

  • Bachelor's degree in Life Sciences, Pharmacy, or Medical Sciences
  • Solid knowledge of local, European, and international PV regulations
  • Fluent in German
    and proficient in English
  • Strong organizational skills and experience in cross-functional collaboration
  • Analytical mindset with problem-solving abilities
  • Excellent communication skills and ability to work in a culturally diverse environment

Interested?
Apply now

Desired Skills and Experience
Bachelor's degree in Life Sciences, Pharmacy, or Medical Sciences

Solid knowledge of local, European, and international PV regulations

Fluent in German and proficient in English

Strong organizational skills and experience in cross-functional collaboration

Analytical mindset with problem-solving abilities

Excellent communication skills and ability to work in a culturally diverse environment

SThree_Germany is acting as an Employment Business in relation to this vacancy.