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.
Yes iam intrest