TH
Job Description
Essential Functions:
- Author and review Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports, ACO, DSUR) for submission to local and other health authorities.
- Author and review Risk Management Plans (RMPs) as part of regular pharmacovigilance activities.
- Author and Quality Review of Signal Management Reports.
- Perform literature searches and validity checks for aggregate reports.
- Manage and reconcile relevant process trackers.
- Serve as a Subject Matter Expert (SME), training and mentoring team members.
- Extract and validate data (RSI, sales, previous reports, RMP, signals).
- Generate Line Listings (LL) from the safety database.
- Provide reliable support for high-priority ad-hoc activities.
- Interact with client personnel to resolve issues related to Aggregate reports in accordance with clients policies.
- Ensure that deliverables comply with relevant regulatory requirements and are delivered within agreed timelines.
Qualifications:
- PhD, M-Pharmacy/B-Pharmacy, or Doctor of Pharmacy (PharmD) from a PCI recognized university or college.
- Preferred: 2-5 years of experience in authoring Aggregate Reports.
- Proficient in computer operations and keyboarding skills.
- Proficient with Microsoft Office Suite (Outlook, Word, Excel).
- Strong verbal, written, and interpersonal communication skills.
- Excellent organization and prioritization skills, capable of multitasking.
- Flexible, able to adapt to fluctuating business priorities.
- Willingness to occasionally work extended and/or flexible schedules to meet client requirements.