• Jobs Job bei PeKo Pharm GmbH

Scientist Medicine as Associate Director - Drug Safety und Pharmacovigilance Biotech (m/f/

PeKo Pharm GmbH

München, Deutschland

Festeinstellung

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m/w

unbefristet

keine Altersbeschränkung

zur Verhandlung

München (Kreis)

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Personalabteilung


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Associate Director Drug Safety und Pharmacovigilance (gn), Biotech Location: Munich Reporting to: VP Drug Safety und Pharmacovigilance Our clients mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by their people, who focus on excellence in all they do, collaborate closely across disciplines. All are driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of our client ?s team is given the opportunity to develop and flourish within this exciting and inspiring environment. Your Responsibilities: Supports the development of a PSMF prior to MAA in Europe Regularly maintains the PSMF Supports the implementation and maintenance of a post-marketing pharmacovigilance system in Europe Supports drug development concerning all aspects of clinical safety Medicalevaluation and assessment of safety data Supports the generation of periodic reports such as DSUR / PSUR, periodic line listing reports Contributes to the generation of safety parts of clinical trial related documents such as Investigator´s Brochure, protocols, patient information and consent forms, clinical study report and clinical and product development plans Supports the Drug Safety Officer / GPO in assessing the medical risk of product complaints and to initiate the necessary actions if needed Your Requirements: A Medical educational background is mandatory At least 10 years of experience in drug safety (both pre- and post-marketing) in a pharmaceutical or biotechnology company Thorough understanding of ICH-GCP, cGMP, EMA Guidelines and European Regulations and Directives, and other national regulatory requirements pertaining to adverse event assessment and reporting Experience in drug approval process for biologic products Able to interpret and apply medical information, instructions, policies, procedures and guidelines pertaining to drug safety Able to interpret safety data and to write safety texts for MAA dossiers Detailed knowledge of the use of drug safety databases, individual case processing experience and practical expertise with MedDRA Experience with preparation and maintenance of a PSMF We offer: Creative working in X-functional teams Open and respectful corporate culture Multicultural environment Working in an attractive, state-of-the-art building with in-house restaurant Free sports and language coursestions, policies, procedures and guidelines pertaining to drug safety Able to interpret safety data and to write safety texts for MAA dossiers Detailed knowledge of the use of drug safety databases, individual case processing experience and practical expertise with MedDRA Experience with preparation and maintenance of a PSMF We offer: Creative working in X-functional teams Open and respectful corporate culture Multicultural environment Working in an attractive, state-of-the-art building with in-house restaurant Free sports and language courses

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