We have an opening for '' Safety Surveillance Advisor'' with Pharma MNC .
Location : Bangalore
Qualification : MBBS + MD ( pharmacology ) will be preferred.
Experience : Relevant exp. of 1 to 2 years.
Establishment of the product safety profile
ïƒ˜ Develop and update the minimum mandatory safety information (MMSI) for use in the Informed Consent
ïƒ˜ Owner of the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for developments products
ïƒ˜ Maintenance of the labelling for marketed products and member of the Product Labelling Committee (PLC) Review Group
ïƒ˜ Perform ongoing and systematic surveillance of all accessible data within allocated product area(s), take initial actions to mitigate risks in case a safety signal or alert is detected or aggravated and document the results of the safety surveillance for the period
ïƒ˜ Conduct periodic literature surveillance for marketed products and for development products (if applicable)
ïƒ˜ Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure (IB), integrated safety summaries, abstracts and planned publications
ïƒ˜ Provide proactive safety communication by participation in project/trial groups/teams established, as appropriate and conduct Investigator training as required
ïƒ˜ Provide answers to enquiries from HAs and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/ Informed Consent (ICs)
ïƒ˜ Establish and ensure deliverables to/from Data Monitoring Committees (DMCs)
ïƒ˜ As author prepare Development Safety Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and clinical Risk Management Plans (RMPs) according to implementation plans or as required by HAs
If interested pls send updated CV at email@example.com