ProPharma Group Hiring Pharmacovigilance Scientist – Aggregate Reports

ProPharma Group Hiring Pharmacovigilance Scientist – Aggregate Reports

21 August, 2022

ProPharma Group Hiring Pharmacovigilance Scientist – Aggregate Reports

Job Description

The PV Scientist, Aggregate Reports will be responsible for the preparation of aggregate reports as per guidelines and work instructions.

Essential Functions Include

  • 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.

Qualified Candidates Must Have

Qualifications

  • PhD, M-Pharmacy/B-Pharmacy, Doctor of Pharmacy (PharmD) from PCI recognized University/College.
  • Fresher or 1-2 years of experience in authoring ARs.
  • 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 requirements.

Apply HERE

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