Pharmacovigilance Vacancy At Orchidia Pharmaceutical
Job Description
- Maintain/Manage PV system.- Establish/Oversight the PV system structure & performance.
- Responsible for ICSRs (Individual Case Safety Report), PSURs (Periodic Safety Update Report), & Other Reports as requested.
- Continuous PV evaluation post authorization.
- Overview of safety and emerging concerns.
- Ensures request from authorities for info on benefit-risk is answered fully and promptly.
- Contact Point for PV inspection.
- Deputy QPPV shall have sufficient authority to influence the performance of the quality system and PV activities to maintain, promote & improve compliance with legal requirements.
- Deputy QPPV should have access to PSMF (Pharmacovigilance System Master File) and be in position of authority to ensure and to verify that the information contained in PSMF is an accurate and up-to-date reflection of the PV system under responsibility.
- Literature searching.
- Safety database change control.
- Safety data exchange agreements.
- Safety data archiving.
- Pharmacovigilance auditing.
- Quality control of PV.
- Training of the personnel on PV.
- Receive PV audits and provide information to the auditors relevant to risk assessment, including knowledge of status of corrective and preventive actions.
- The Pharmacovigilance system master files (The system that describes the whole pharmacovigilance system inside the company).
- The Routine Literature search to see updates about active ingredients.
- Training of the new medical reps & the current, new employees (to know how to report the complains).
- Submission of PSURs (Periodic safety update report ) upon request of M.O.H
- The new part, which is the essential role in registration of each new product:
- After the box approval the company has to submit the following :
- I) The Pharmacovigilance system master file & its summary.
- II) Risk management plan for the active ingredients (if existed, Make an Egyptian display for it … If not, make declaration).
- Involved in any clinical trials, market research or any post authorization safety studies.
- Patient support programs (Awareness Campaigns).
- Preparing Dear Doctor letters.
- Exciting assigned tasks with regard to Export department.
Skills
- Be appropriately qualified & experienced / trained (has adequate theoretical & practical knowledge for the performance of PV activities).
- Deputy QPPV shall have a minimum Bachelor of Pharmacy or Medicine.
- Residing in Egypt.
- Have the skill for the management of PV systems In case of absence of QPPV.
Career Level
Entry Level
Years of Experience
Min: 1 Max: 3
Residence Location
Egypt
Nationality
Egypt
Degree
Bachelor's degree
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