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Associate Manager Drug Safety and Public Health

Eingestellt von Aerotek

Projektbeschreibung

Associate Manager, Drug Safety and Public Health - 6 month contract - Cambridgeshire

This is an exciting opportunity for an Associate Manager, Drug Safety and Public Health on a 6 month contract with a global pharmaceutical company based in Cambridgeshire. This individual will be authoring aggregate safety reports including PSURs and ASRs, risk management plans and CCDS sections. This is a rapidly growing company and an excellent time to join the team. This company is very people orientated and has an extremely friendly working environment.

Essential duties and job functions will be:
Signal detection and workups.
Authorship of CCDS sections and associated supporting documentation.
Authorship of aggregate safety reports including PSURs and ASRs.
Authorship of risk management plans.
Authorship of responses to regulatory agency safety enquiries.
Contribution to safety analyses in Regulatory submissions (eg MAAs, NDAs).
Contribution to safety committee meetings (internal or with partner companies).
Works effectively in partnership with safety physicians.
Develops contacts across the company and use those contacts to manage projects more effectively.
Works effectively both independently and within a team and collaborates cross-functionally when required.
Ability to lead projects with some supervision.

Knowledge, Experience and Skills:
Sound knowledge of pharmacovigilance, regulations, aggregate safety reports, risk management plans, signal detection.
Familiar with searching drug safety and literature databases for relevant information
Able to work effectively to tight timelines.
Good scientific and analytical skills.
A systematic and logical approach to problem solving.
Must have an excellent attention to detail combined with the ability to present complex information clearly (in verbal and written form).
Must be proficient in Word, Microsoft Excel and Powerpoint.
Must have significant and relevant safety signal detection and evaluation/risk management experience and a BSc or equivalent degree in a Biomedical or Healthcare related discipline.

Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice.

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Aerotek