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Embark on a fulfilling career journey as a Pharmacovigilance Scientist with ProPharma, a renowned pharmaceutical company based in Hyderabad! We’re thrilled to offer a rewarding career opportunity for passionate individuals looking to make an impact in drug safety and regulatory compliance.
As a Pharmacovigilance Scientist at ProPharma, you’ll play a crucial role in ensuring the safety and efficacy of pharmaceutical products, contributing to the well-being of patients worldwide. If you’re ready to leverage your expertise and drive innovation in pharmacovigilance, seize this opportunity to join our dynamic team. Explore the possibilities and take the next step towards a rewarding career in drug safety with ProPharma.
Job Title – Pharmacovigilance Scientist
Qualification – PhD, M-Pharmacy/B-Pharmacy, Doctor of Pharmacy (PharmD) from PCI recognized University/College.
Experience – Preferred: 2-3 years of experience in ICSR Case Processing.
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Job Summary
- Monitoring of incoming reports from various sources including mailboxes, EudraVigilance, and literature search results.
- Downloading of L2A (Regulatory authority) and MLM cases from EV Web regularly by using client-specific filters for the triage process.
- Triage of incoming reports for completeness, duplicate checks, legibility, and validity.
- Perform literature searches according to the search strategy.
- Responsible for case processing or quality review of coding all medical history, events, drugs /procedures/indication, and laboratory tests according to the appropriate dictionary such as MedDRA, Company Product Dictionary, WHO-DD
- Responsible for writing or reviewing medically relevant safety narratives of cases and checking the completeness and accuracy of the data entered in the various fields.
- Performs clear and accurate data capture of cases following client conventions/guidelines and Standard Operating Procedures (SOPs).
- Ensures that the expectedness, causality assessment, as well as seriousness criteria, are accurate for the events.
- Request follow-up and perform query management, as applicable.
- Maintaining respective trackers required for the process and client delivery.
- Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for adverse event reporting.
- Attending internal, drug safety, and project-specific training sessions.
- Performs training assigned on internal and client Learning Management System (LMS) as applicable within designated timelines.
Necessary Skills and Abilities:
- Excellent verbal, written, and interpersonal communication skills.
- Strong organization and prioritization skills; able to multitask.
- Computer proficiency, expertise, and an ability to deal with web-based applications, email, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/PowerPoint).
- Understanding of patient safety regulatory obligations.
- Flexibility to adapt and meet fluctuating business priorities.
- Able to occasionally work extended and/or flexible schedules to meet client requirements.
- Capability to work collaboratively as well as efficiently in a team environment.
Official Website – www.propharmagroup.com
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