Company: Pharmalink Consulting
Closing Date: 03 Nov 16
Salary (£): Competitive
Genpact Pharmalink is a highly specialized Regulatory Affairs Consultancy with a successful history. We have grown and developed our service offering through building relationships, listening to our clients’ needs and adapting our ways of working to meet the changing needs of regulatory markets around the world. It is this flexibility and adaptability that we look for in all of our Consultants.
•To assist with and support all local safety related activities as directed by the UK and Ireland Head of Drug Safety
•Ensure compliance with local and international regulations and Clients internal standards.
•To execute timely local case-processing activities, including ensuring robust investigation and follow-up of local safety reports for both marketed products and those under development.
•To assist with timely and accurate reporting to the national competent authorities.
•To contribute effectively as part of the Client Global Safety network
Role and Responsibilities:
SAE/AE Case Processing
•To ensure the accurate, timely and complete receipt, evaluation and follow- up of domestic adverse event reports.
•To maintain the local archive of safety reports
•To maintain current awareness of local and global safety regulations
•To ensure compliance with local expedited and periodic regulatory reporting requirements for marketed products and those under development, utilizing ARISg and E2B.
•To contribute to the development and maintenance of corporate policies, standard operating procedures and associated documents on safety data handling.
Internal affiliate development
•To assist with training of the affiliate organisation and associated third parties on safety data reporting requirements
•To capture, follow-up and ensure the appropriate persons within Client are notified of locally reported Product Quality Complaints.
Skills and Knowledge Requirements:
•Life science/Pharmacy degree or Registered Nurse
•Attention to detail
•Ability to follow standard operating procedures
•Be able to work independently and as part of a team
•Strong identification with Client’s values
•Excellent written and verbal communication skills
Leadership Competencies (Behaviours)
•Foster Teamwork-Individual Contributor Behaviors
•Demonstrate Adaptability- Individual Contributor Behaviors
•Promote Open Communication- Individual Contributor Behaviors
•Drive Execution -Individual Contributor Behaviors
Vanwall Business Park
|Tel:||+44 (0) 1628 860300|
|Fax:||+44 (0) 1628 860400|
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