Drug Safety Associate

vor 2 Monaten

Munich, Deutschland OPTARES Gmbh & Co. KG Vollzeit

[6029]

Our client is a NASDAQ listed biotechnology company with the global Headquarter in Germany. The companies focus is the research and development of new medicines for the treatment of inflammatory diseases within a global development approach. Our client stands out for an excellent team of highly motivated and skilled individuals who put strong emphasis on a team effort.

To support our team we are looking for a

**Drug Safety Associate (M/F/d)**

Your tasks
- Support the management of third-party Pharmacovigilance vendor processes and internal processes for safety activities within an ongoing phase II to phase III clinical program and a post-marketing study
- Receiving, tracking, and filing of SAEs/AEs and expedited event reports (SUSARs/ADRs) including surveillance of timely processing by third-party vendor
- Provide sponsor oversight of SAE/AE/ADRs/SUSARs processing by an outsourced vendor including the monitoring of reporting compliance
- Co-ordinate case review with InflaRx Medical Affairs personnel and ensure implementation of recommendations
- Co-ordinate on time for data preparation with third-party vendor for periodic safety assessment (DSUR, IB, DSMB, PADER)
- Contribute to vendor surveillance with regards to invoice verification and cost control
- Ensure compliance with SOPs, GCP, and relevant regulatory environment of activities and documentation
- Maintain knowledge of adverse event reporting processes and safety systems and contribute to the development, implementation, improvement, and standardization of new processes and methods

Ihre Qualifikationen
- Bachelor’s degree in Life Sciences/Pharmacy/Medical Sciences, or other equivalent experience/education
- A minimum of 6 months of relevant experience in a pharmaceutical/ biopharmaceutical organization with safety reporting (expedited/periodic) in clinical development and post-marketing studies (US and European countries)
- First-in-hand experience with safety reporting and regulatory reporting in clinical development and post-marketing environment
- Ability to work harmoniously within international cross-functional teams, engage in open, constructive and continuous dialogue with internal staff and external partners
- Goal oriented and flexibility to adapt to changing situations in a fast-paced environment
- Highly motivated, self-driven, dependable, and solution oriented
- Effective communication skills
- Fluent in written and verbal English (business level proficiency needed). Fluency in German desirable
- Should be familiar with MS Word, Excel and PowerPoint

  • Associate, Drug Safety Dach

    Vor 4 Tagen

    Munich, Deutschland Biogen Vollzeit

    **Qualifications** For our Munich office (in a hybrid working model) we are recruiting for an **Associate, Drug Safety DACH (f/m/d)** in temporary employment via 3rd party. The position will be responsible to support all relevant PV activities within the DACH region. This includes but is not limited to routine activities as reconciliation activities,...

  • Associate Director, DACH Regional Drug Safety Lead

    vor 2 Monaten

    Munich, Deutschland Biogen Vollzeit

    Job Description For our office in Munich (in a hybrid working model) we are recruiting for a  Associate Director, DACH Regional Drug Safety Lead (f/m/d)  The Associate Director, DACH Regional Drug Safety Lead (f/m/d) is responsible for leading the Drug Safety departments for the DACH region (Germany, Austria, Switzerland), including line...

  • Associate Director, DACH Regional Drug Safety Lead

    Vor 5 Tagen

    Munich, Deutschland Biogen Vollzeit

    Job Description For our office in Munich (in a hybrid working model) we are recruiting for a  Associate Director, DACH Regional Drug Safety Lead (f/m/d)  The Associate Director, DACH Regional Drug Safety Lead (f/m/d) is responsible for leading the Drug Safety departments for the DACH region (Germany, Austria, Switzerland), including line...

  • Leiter Drug Safety

    vor 2 Monaten

    Munich, Deutschland LMU Klinikum Vollzeit

    Ihr Aufgabenbereich Operative Leitung des Safety-Teams (Arzneimittel- und Medizinprodukte) Weiterentwicklung des Safety-Teams hinsichtlich strategischer Ziele, neuer gesetzlicher Anforderungen, neuer Technologien etc. Sicherstellung der lokalen Compliance gemäß externer und interner Vorgaben im Bereich Safety Weiterentwicklung/Ausbau der Safety...

  • Leiter Drug Safety

    Vor 2 Tagen

    Munich, Deutschland LMU Klinikum Vollzeit

    Ihr Aufgabenbereich Operative Leitung des Safety-Teams (Arzneimittel- und Medizinprodukte) Weiterentwicklung des Safety-Teams hinsichtlich strategischer Ziele, neuer gesetzlicher Anforderungen, neuer Technologien etc. Sicherstellung der lokalen Compliance gemäß externer und interner Vorgaben im Bereich Safety Weiterentwicklung/Ausbau der Safety...

  • Senior Peptide Expert Drug Safety

    vor 1 Monat

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: Peptide drugs are one of the most exciting areas in the pharmaceutical industry. You have experience in the non-clinical safety evaluation of peptide therapeutics and would like to contribute on an efficient development for optimal patient benefit? We offer the chance of a scientific leadership position within the department of...

  • (Senior) Drug Safety Associate

    vor 2 Wochen

    Munich Metropolitan Area, Deutschland Constares GmbH Vollzeit

    Unser Kunde ist ein führendes biopharmazeutisches Unternehmen mit Sitz der deutschen Marketing- und Vertriebsniederlassung in München.Wir suchen eine kommunikationsstarke (Senior) Drug Safety Associate (m/w/d) zur Unterstützung des Teams unseres Kunden in allen relevanten Pharmakovigilanz (PV)-Aktivitäten in der DACH-Region. Dies umfasst unter anderem...

  • (Senior) Drug Safety Associate

    Vor 4 Tagen

    Munich Metropolitan Area, Deutschland Constares GmbH Vollzeit

    Unser Kunde ist ein führendes biopharmazeutisches Unternehmen mit Sitz der deutschen Marketing- und Vertriebsniederlassung in München.Wir suchen eine kommunikationsstarke (Senior) Drug Safety Associate (m/w/d) zur Unterstützung des Teams unseres Kunden in allen relevanten Pharmakovigilanz (PV)-Aktivitäten in der DACH-Region. Dies umfasst unter anderem...

  • Senior Peptide Expert Drug Safety

    vor 1 Monat

    Munich, Deutschland Boehringer Ingelheim Vollzeit

    **The Position** Peptide drugs are one of the most exciting areas in the pharmaceutical industry. You have experience in the non-clinical safety evaluation of peptide therapeutics and would like to contribute on an efficient development for optimal patient benefit? We offer the chance of a scientific leadership position within the department of non-clinical...

  • Leiter Drug Safety

    vor 1 Monat

    Munich, Deutschland Klinikum der Universität 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 11.000 Mitarbeiterinnen und Mitarbeiter beteiligt. Ihr...

  • Working Student, Drug Safety

    vor 1 Monat

    Munich, Deutschland Biogen Vollzeit

    **Job Description**: For our Munich office (in a hybrid working model) we are looking for a **Working Student, Drug Safety (f/m/d).** We offer you the opportunity to actively contribute as a working student (f/m/d) and gain insight into diverse and exciting topics. Through your work in the day-to-day business and various projects, you will gain a...

  • Technical Assistant Nonclinical Drug Safety Germany

    vor 2 Monaten

    Munich, Deutschland akut... Kompetente Lösungen GmbH Vollzeit

    Wir suchen für unseren langjährigen Kunden aus der pharmazeutischen Branche in 88400 Biberach-Riss **ab sofort vorläufig für 1 Jahr **eine/n **Technical Assistant Nonclinical Drug Safety Germany / General Toxicology (m/w/d)** Monatsgehalt: 4.100 Euro bis 5.400 Euro - Unser Kunde ist ein Pharmaunternehmen, welches 1885 gegründet wurde und das größte...

  • Sales Associate

    vor 1 Monat

    Munich, Deutschland Selleck Chemicals GmbH Vollzeit

    **No biology background needed.** **We are hiring immediately for a full-time Sales Associate position.** **Salary**: 30.000,00€-75.000,00€ per year We are looking for **Sales Associate, **who are dedicated sales professionals who can promote our collection of small molecule drugs and develop our academic accounts. We offer comprehensive biology...

  • Safety Associate

    vor 1 Monat

    Munich, Deutschland GKM Gesellschaft für Therapieforschung Vollzeit

    THINK BEYOND! - CHOOSE PASSION! - AND IMPROVE YOUR QUALITY OF LIFE. UNSERE PHILOSOPHIE Als moderne CRO schreibt GKM fachliche Kompetenz, Erfahrung, Flexibilität und Kreativität im Arbeitsalltag groß. Durch die Wahrung des Dienstleistungscharakters gegenüber seinen Kunden zeichnet sich das Unternehmen seit vielen Jahren durch Kontinuität und stetiges...

  • Associate Director Computational Chemistry

    Vor 3 Tagen

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: Take advantage of your experience, establish agile research strategies, embrace collaborative design thinking, and actively shape a sustainable research project pipeline that addresses unmet medical needs. As drug discovery expert, you combine a drug discovery industry background with scientific expertise in computational chemistry. You...

  • (Senior) Director Clinical Safety Oncology

    vor 1 Monat

    Munich, Deutschland Daiichi-Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: **(Senior) Director Clinical Safety Oncology (M/F/x)**: **The position**: The (Senior) Director Clinical Safety Oncology is responsible for the overarching, global safety strategy and risk management activities, across the lifecycle, for his/her assigned oncology product (i.e. Antibody Drug Conjugation...

  • Director Clinical Safety

    Vor 4 Tagen

    Munich, Deutschland Daiichi Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to...

  • Safety Physician

    vor 3 Wochen

    Munich, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading...

  • Health & Safety Advisor

    Vor 5 Tagen

    Munich, Bayern, Deutschland VF Corporation Vollzeit

    VF Corporation is looking for an exceptional local Health and Safety advisor to join our Team team based in Munich, Germany.Let's talk about the role As the local Health and Safety advisor of a country, you are directly responsible for keeping local management and EMEA H&S management informed on all levels of risk and informing your line manager (legal...

  • Health & Safety Advisor

    vor 2 Wochen

    Munich, Deutschland VF Corporation Vollzeit

    VF Corporation is looking for an exceptional local Health and Safety advisor to join our Team team based in Munich, Germany.Let's talk about the role! As the local Health and Safety advisor of a country, you are directly responsible for keeping local management and EMEA H&S management informed on all levels of risk and informing your line manager (legal...