Associate Director

vor 9 Stunden

Stuttgart, Deutschland CureVac Vollzeit

CureVac SE is a global biopharmaceutical company researching and developing novel drugs based on the natural molecule Messenger RNA (mRNA). Our focus is on prophylactic vaccines, innovative cancer immunotherapies and protein-based therapies. Currently, all _RNA people _are striving to achieve our main goal: To bring multiple best-in-class mRNA drugs to market.

To strengthen our team in Tübingen near Stuttgart, we are currently looking to recruit an

**Associate Director (f/m/d) Drug Safety**

**Your responsibilities**:

- Fulfilling all Drug Safety activities for investigational compounds towards respective Regulatory Authorities
- Contact point for all Drug Safety matters for investigational compounds as assigned within CureVac and for business partners
- Develop and contribute to risk management strategies for investigational compounds and market products
- Collaborate with CureVac Interface departments to further strengthen processes as applicable
- Oversight of respective Pharmacovigilance (PV) service providers and/or business partner acting on behalf of CureVac
- Support PV activities for CureVacs’ investigational medicinal products (and market/authorised medicinal products) specifically in the collection, reporting and analyses of safety data; identifying, detecting and investigating safety signals
- Single case safety review, aggregated periodic safety review in clinical trials as well as for marketed/authorised medicinal products including signal detection, validation and assessment, continuous risk benefit evaluation, safety analysis for assigned products
- Support development of the PV quality assurance system required to ensure the company's compliance with respect to patient safety laws, regulations and guidance associated with the development and licensure of the company’s medicinal products
- Knowledge in and compliance with PV relevant regulations
- Support audits and Health authority inspections

**Your qualifications**:

- MD or Life Science degree or equivalent qualification
- Several years of experience as a Drug Safety professional with focus on clinical safety, but also PV background in pharma/biotech and/or CROs
- Independent working style but also a team player
- Strong communication and presentation skills
- Detail oriented way of working and problem solving and pragmatic attitude
- Flexible and used to changing priorities
- Fluency in English, German is a plus

We offer you a challenging and varied opportunity with an innovative and dynamic company that is expanding.
With much passion and sense of responsibility, we work together on the medical revolution. We pride ourselves on maintaining an honest and trusting relationship with each other which is characterized by openness to new ideas and continuous progress. Mutual respect, reliability and personal initiative are self-evident for us.

Design your future with us - become part of the _RNA_ _people_

**CureVac SE**

Human Resources
Julia Daake
Friedrich-Miescher-Straße 15
72076 Tübingen

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