21 Apr

Scientist Jobs Vacancy in Aspen Holdings

Position
Scientist
Company
Aspen Holdings
Location
Opening
21 Apr, 2018 29 days ago

Aspen Holdings urgently required following position for Scientist. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

Scientist Jobs Vacancy in Aspen Holdings Jobs Details:

ROLE PURPOSE:

The PV Scientist provides support for various Pharmacovigilance operations, in particular the medical and scientific functions with respect to safety evaluations of all Group products across Aspen Affiliate companies for which marketing authorisations are held.

KEY RESPONSIBILITIES:

  • Manage outsourced data collection, organisation and preparation with vendors as required
  • Act as Subject Matter Expert (SME) in designated area (e.g. literature, signal management, aggregate reports etc.) responsible for oversight and coordination of tasks related to that area
  • Preparation of ad-hoc and scheduled aggregate safety reports
  • Ensure Good Documentation Practice
  • Maintain awareness of Pharmacovigilance regulatory requirements and developments
  • Contribute to agreed PV Team quality and compliance targets
  • Serve in a leadership capacity for complex and strategically important Pharmacovigilance developmental programs
  • Direct interaction with Regulatory Authorities

Financial:

  • Identification of project challenges to departmental line management and the financial impact thereof.

Medical Writing Accountabilities:

  • Write clinical documents for submission to regulatory authorities, including but not limited to:
  • clinical overviews and summaries
  • integrated summaries of safety and efficacy
  • Clinical Expert Statements

Safety:

  • Creation and update of SOPs/WINs for all pharmacovigilance activities related to the job role in line with worldwide Pharmacovigilance and EU regulations/guidelines
  • Preparation of aggregate safety reports including but not limited to PSURs, PBRERs and Addendum Safety Reports
  • Preparation of Risk Management Systems including but not limited to Risk Management Plans, Dear Healthcare Professional Letters and Risk Communication Plans
  • Manage safety related requests from regulatory agencies and Aspen Affiliates to ensure any requests are answered fully and promptly
  • Review worldwide literature for designated products and identify safety issues/ ICSRs in a timely manner
  • Coordinate and prepare appropriately for signal management meetings
  • Signal Management Activities including compilation of Signal Assessment Reports/ Case Series Reviews for potential signals
  • Creation and update of Safety Data Exchange Agreements (SDEAs)

Training:

  • Oversee training and mentoring of other Pharmacovigilance staff, and prepare training materials as requested
  • Lead initiatives to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance Safety activities

Miscellaneous:

  • Maintain rigorous adherence to written procedures, e.g. SOPs/WINs
  • Adherence to Company Health & Safety procedures
  • Participate in training programmes
  • Any other duties as assigned by your Manager

Requirements

QUALIFICATIONS & EXPERIENCE:

  • Biological/life Sciences Degree or equivalent
  • Documented experience in all aspects of pharmacovigilance
  • Experience working with safety databases
  • Experience writing large safety reports e.g., DSURs, PADERs, PSURs, PRBRERs, RMPs is desirable

Experience working with MedDRA coding dictionary

KNOWLEDGE:

  • Pharmacovigilance practice and procedure
  • EU Competent Authorities and Regulations
  • Marketing Authorisation rules and regulations
  • Knowledge of principles of epidemiology and statistics
  • Good working knowledge of the relevant information sources: including printed publications, unpublished sources, databases, web sites, other departments, external bodies
  • Good documentation practice
  • Knowledge and information sharing
  • Excellent attention to detail
  • Excellent written and oral communication skills
  • Understanding of the principles of information storage and retrieval and skill in their application
  • Awareness of competitor products and activity. Excellent interpersonal and communications skills
  • A solutions provider with strong multi-tasking abilities
  • Manage evolving deadlines effectively with regular feedback and updates
  • Enthusiasm and drive to take ownership and drive process initiatives
  • Occasional travel may form part of the job
Work Level
Senior
Type
Permanent
Salary
Market Related
Location
Europe - Ireland


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