- 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 asMedDRA, 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.
- Performstraining assigned on internal and client Learning Management System (LMS) as applicable within designated timelines.
- 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
- PhD, M-Pharmacy/B-Pharmacy, Doctor of Pharmacy (PharmD) from PCI recognized University/College.
- Preferred: 2-3 years of experience in ICSR Case Processing.
Pharmacovigilance Scientist - Hyderabad, India - ProPharma Group
Description
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world's largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
Job Summary
Necessary Skills and Abilities:
Educational Requirements:
Experience Requirements:
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***