Pharmacovigilance Scientist, ICSR (India) vacancies in Hyderabad for Freshers & Experience Candidates

Job Description

The PV Scientist will be responsible for processing of ICSRs (Individual Case Safety Reports) with a great working knowledge of the adverse event safety profile of the assigned drugs, labelling documents, client’s guidelines, SOPs, and Global drug safety regulations.

Essential Functions Include:

Monitoring of incoming reports from various sources viz mailboxes, EudraVigilance and literature searches etc.
Downloading of L2A (Regulatory authority) and MLM cases from EV Web on regular basis by using client specific filters for triage process.
Triage of incoming reports for completeness, duplicate check, legibility, and validity.
Perform literature searches according to search strategy.
Responsible for sending translation requests.
Responsible for data entry of individual case safety reports into the safety database
Full data entry including medical coding and safety narrative

As Medical Coder:

Responsible for coding all medical history, events, drugs /procedures/indication and laboratory tests according to the appropriate dictionary (For e.g., MedDRA, Company Product Dictionary, WHO-DD)

As Narrative Writer:

Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
Performs clear and accurate data capture of cases in accordance with 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 of 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 the adverse event reporting
Attend internal, drug safety and project-specific training sessions
Finishes training assigned on internal and client Learning Management System (LMS) as applicable
Liaising as well as collaborating with the relevant function at the client’s end to help with the delivery of high-quality work.

Qualifications

Qualified candidates must have:

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

Experience:

Fresher 0-2 years of experience in case processing.
Excellent verbal, written and interpersonal communication skills.
Strong organization and prioritization skills; able to multitask.
Computer proficiency, IT skills, the expertise, and an ability to deal with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/PowerPoint).
Capability to evaluate data and draw conclusions independently.
Understanding of patient safety regulatory obligations
Flexibility to adapt and meet fluctuating business priorities.
Able to occasionally work extended and/or flexible schedule to meet client requirements.
Capability to work collaboratively as well as efficiently in a team environment.
Client focused approach to work

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting