Senior Pharmacovigilance Scientist
Location
Secunderabad | India
Job description
Job Summary:
- 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 the 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 schedules to meet client requirements
- Must be good at commonly used software i.e (word, PowerPoint, excel)
Educational Requirements:
- PhD, M-Pharmacy/B-Pharmacy, Doctor of Pharmacy (PharmD) from PCI recognized University/College.
Experience Requirements:
- Preferred: 2-5 years of experience in authoring ARs and at least 1-2 years of exposure to Quality review.
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