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Emploi > Emplois > Médecine/Santé > Allemagne > Darmstadt > Détails de l'offre 

Safety Strategy Lead (all genders)

Entreprise non montrée
 Darmstadt, Allemagne
Médecine/Santé, Anglais
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Description du poste:

The role:

The position Safety Strategy Lead is to ensure the delivery of integrated medical safety strategies for assigned development compound(s) and/or marketed product(s) including proactive safety surveillance and effective signal and benefit-risk management. The role will set the medical safety strategic direction, in the context of delivering the benefit-risk profile, and provide clear, strong and visible safety scientific leadership, in partnership with R&D cross-functions. The Safety Strategy Lead will ensure oversight of the emerging safety profile of the product, including medical review of individual case safety reports as required, signal detection and evaluation, periodic safety reporting, risk-benefit evaluation and risk management throughout the lifecycle of the product.

Who you are:

* Physician with broad clinical experience

* Several years of medical experience as a physician, preferably clinical experience in the relevant therapeutic area

* Broad industry experience (minimum 5 years), preferably including both clinical development and pharmacovigilance experience; excellent knowledge of the pharmacovigilance regulations/guidelines and its application for activities related to assigned product/s

* Excellent knowledge of product development process and experience of cross-functional teamwork

* Preferentially prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files

* First-hand experience in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, hematological) and good medical understanding of the relevant therapeutic area(s)

* Expert knowledge of aggregate data analytics and understanding of related sciences such as predictive modelling, epidemiology, health outcomes and biostatistics

* Professional experience in a global matrix environment across regions

Job Requisition ID: 2xxxx1

Location: Darmstadt

Career Level: D - Professional (4-9 years)

Working time model: full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 8xx xxx xxx8 from 8:00am to 5:30pm ET Monday through Friday

Origine: Site web de l'entreprise
Publié: 16 Avr 2020
Langues: Anglais
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