Drug Safety Scientist

Conteúdo do emprego

Description

JOB TITLE: Senior PV Scientist

Job Summary

Senior PV Scientist serves as a global product lead for Pharmacovigilance activities within Safety. The Senior PV Scientist is responsible for overseeing and leading the process for safety signal management activities, aggregate reports (PSURs, DSURs, Line Listings, RMPs), responding to safety questions from internal and external stakeholders, reviewing the medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities. The Senior PV Scientist, along with the Associate Director is responsible for hiring, training, mentoring and managing staff within their assigned products. The Senior PV Scientist also serves as a Subject Matter Expert for Safety and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information. In this capacity, the Sr. PV Scientist is critical to ensure products in clinical trials continue to maintain good standing with countries where studies are ongoing to ensure clinical studies are completed, and for marketed products, ensures the marketing authorization remains in good standing.

Responsibilities

• Leads the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Leads signalling review process and product Safety Signaling Team meetings. Manages literature review for safety information.
• Leads the process for responding to safety questions from regulatory authorities.
• Leads Aggregate Report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).
• Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned.
  

Skills

• Safety
• Safety management
  

Employee Value Proposition

remote 100%

Job Title: Drug Safety Scientist

Location: Baar, Switzerland

Job Type: Contract

Aerotek, an Allegis Group company. Allegis Group AG, Aeschengraben 20, CH-4051 Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek is a company within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to https://www.allegisgroup.com/en-gb/privacy-notices.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice at https://www.allegisgroup.com/en-gb/privacy-notices for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield