Pharmacovigilance Scientist Openings In Hyderabad - PV - PHARMA STUFF

pharmacovigilance scientist Openings in Hyderabad – PV

  • Full Time
  • Hyderabad
  • ₹300000 - 500000 INR / Year
  • Hyderabad
  • Postal Code: 500082
Region: Telangana

Website Propharma group

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

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pharmacovigilance scientist Openings in Hyderabad - PV
pharmacovigilance scientist Openings in Hyderabad – PV

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