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