Pharmacovigilance Scientist

Location

Secunderabad | India

Job description

• 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

Educational Requirements:

• PhD, M-Pharmacy/B-Pharmacy, Doctor of Pharmacy (PharmD) from PCI recognized University/College.

Experience Requirements:

• Preferred: 2-3 years of experience in ICSR Case Processing.

Job tags

Salary