Job Description

Authoring and review of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities. Authoring and review of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities. Authoring /Quality Review of Signal Management Reports. Performing literature search and validity check for the aggregate reports. Management and reconciliation of relevant process trackers. Subject matter expert (SME) along with training and mentoring of individuals. 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. Interacting with appropriate client personnel to resolve issues related to the Aggregate reports as per clients policies. Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines. Essential Functions: Drafting and review of PBRER, PSUR, DSUR, PADER, Annual Report and Signal reports. Necessary Skills and Abilities: Proficient computer knowledge and computer keyboarding skills. Proficient with Microsoft Office Suite (Outlook, Word, Excel). Strong verbal, written and interpersonal communication skills. Strong organization and prioritization skills; able to multitask. Flexibility to adapt and meet fluctuating business priorities. Able to occasionally work extended and/or flexible schedule to meet client requireme Must be good at commonly used software i.e (word, power point , excel) Educational Requirements: PhD, M-Pharmacy/B-Pharmacy, Doctor of Pharmacy (PharmD) from PCI recognized University/College. Experience Requirements: Preferred: 2-7 years of experience in authoring ARs and at least 1-2 year of exposure to Quality review.

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