NAMED SAFETY CONTACT
GSK is one of the world’s leading research-based pharmaceutical and healthcare companies. An exciting career opportunity has risen for a highly motivated and enterprising individual to join the organization as a Named Safety Contact.
The successful candidate’s principal purpose will b to ensure that GSK East Africa complies with Regulatory Pharmacovigilance reporting requirements for reporting Spontaneous adverse events for marketing product and Serious adverse events for Clinical trials being conducted in the East African Region.
Essential Job Responsibilities:
· Ensure full compliance with the Operating Company SOP for the receipt, investigation and reporting of adverse events.
· Update and maintain the register of all post-marketing AE, incidents and pregnancy reports.
· Working with the local regulatory department to develop a controlled document describing the process for handling queries and commitments from the Regulatory Authority.
· Ensuring a robust process is in place for the receipt of spontaneous case reports outside business hours.
· Monitor locally published medical and scientific literature.
· Forwarding to the relevant Central Safety Department any reports involving GSK medicinal or consumer Healthcare products or medical devices published in the local media (e.g. newspapers and lay journals).
· Reviewing all local clinical study proposals/protocols to ensure adequate safety requirements are met.
· Ensure that there is an established process for liaison with the relevant departments dealing with product complaints and medical enquiries.
· Providing training to Operating Company staff including field-based representatives and clinical development staff on Pharmacovigilance.
· Maintaining a list of all GSK medicinal products, and medical devices marketed locally and where relevant details of the EU Qualified Person for Pharmacovigilance for each product
Qualifications & Knowledge:
· Bachelor degree qualification in life sciences.
· Attention to details and focused.
· Excellent organizational skills.
· Good communication and presentation skills.
· Good understanding of the Regulatory environment.
Interested candidates should apply stating their overall suitability for the position together with a detailed CV that clearly addresses the ability to perform the key responsibilities to: QYZ72406@gsk.com
The application deadline is 25th March 2011
Please Note that only shortlisted Candidates will be contacted
