29 July, 2022
ProPhrama Group Hiring Pharmacovigilance Scientist – Freshers can Apply
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.
Qualified Candidates Must Have
- PhD, BDS, M-Pharmacy/B-Pharmacy, Doctor of Pharmacy (PharmD) from PCI recognized University/College.
- 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.