Sr. Executive / Assistant Manager - Aggregate Reports

Sr. Executive / Assistant Manager - Aggregate Reports

1 Nos.
106855
Full Time
3.0 Year(s) To 6.0 Year(s)
4.00 LPA TO 6.50 LPA
Engg Design / R&D / Product Mgt
Pharma/Biotech/Clinical Research
B.Pharma - Pharmacy; M.Pharma - Pharmacy
Job Description:

Roles & Responsibilities:
• Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR for
submission to local and other Health Authorities.
• Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.
• Authoring of Signal Management Reports.
• Performing literature search and validity check for the aggregate reports.
• Reconciliation of relevant process trackers.
• Extraction and validation of data (RSI, Sales, previous reports, RMP, signals).
• Generation of Line Listings (LL) from safety database
• Providing reliable support for high priority Ad-hoc activities.
• Ensure all the reports are drafted within the allocated timelines.

 

B Pharm/MPharm/ BDS

 
Company Profile

company is constantly consolidating the position as one of the best service provider for Pharmaceutical Research and Development to pharmaceutical companies worldwide. They are putting all efforts in order to fulfil our vision by sticking to set quality standards, by strengthening the long-term business connections and by establishing partnerships in the fields of pharmaceutical research and development.

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