Auftragsdetails

Detailed Description

The PV Scientist (ICSR process) is primarily responsible for case processing tasks from intake through query management. In parallel, the PV Scientist (ICSR process) performs literature searches according to a set strategy.

Processing of all types 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 applicable Global drug safety regulations.

Essential Functions:

• 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 on regular basis by using client specific filters for triage process.
• Triage of incoming reports for complete Agreeness, duplicate check, legibility, and validity.
• Perform literature searches according to search strategy.
• Responsible for 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 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).
• 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 adverse event reporting.
• 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.
• 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 schedule to meet client requirements.
• Capability to work collaboratively as well as efficiently in a team environment.

Educational Requirements:

• M-Pharmacy/B-Pharmacy, Doctor of Pharmacy (PharmD) and BDS from National Government recognized University/College.

Experience Requirements:

• 1-3 years of experience in ICSR (Individual Case Safety Reports) processing.

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.***