Pharma Safety Science Coordinator Vacancy 2020 – Covance
Covance Pharma Jobs. B Pharma candidates are encouraged to apply online for the Safety Science Coordinator II vacancy that is available at Covance. Covance Mumbai Job openings for Pharmacology candidates. Check out all of the details on our website Rasayanika.com
Job Title: Safety Science Coordinator II
Education/Qualifications:
Bachelors/Masters in Pharma OR Pharm D.
Experience:
3+ years in PV.
Responsibilities:
Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
- the entry of safety data onto adverse event database(s) and tracking systems
- review of adverse events for completeness, accuracy, and appropriateness for expedited
reporting - write patient narratives
- code adverse events accurately using MedDRA
- determine expectedness/listedness against the appropriate label
- identifies clinically significant information missing from initial reports and ensures its
collection - ensure case receives the appropriate medical review
- prepare follow-up correspondence consulting the medical staff accordingly,
- ensure all cases that require expediting reporting to worldwide regulatory agencies are
processed swiftly and appropriately within required timelines - reporting of endpoints to clients, regulatory authorities, ethics committees,
investigators and Covance project personnel, if required, within study specified
timelines - provide independent QC of AE reports for other members of the group
May execute a routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support. - Maintain a strong understanding of Covance’s safety database conventions or client-specific database conventions, as appropriate.
- Participate in signal detection, trend and pattern recognition activities, as appropriate.
Prepares timely pharmacovigilance reports for products and safety issues, including Individual - Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports,
European Annual Safety Reports (ASRs), Development Safety Update Report (DSUR)
Periodic Reports (PRs) line listings, and aggregate reports. - Begin to participate and demonstrate leadership on projects which enhance team and/or
division performance. This includes acting as lead contact for projects including global
projects ensuring communication and process harmonization. - Work with Data Management or client on reconciliation of safety databases, if appropriate.
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