Drug Safety Officer & QPPV - IsraelApply Now Email Me Job ID R0011456 Date posted 08/29/2019 Location: Petah Tikva, Israel
Job Title: Drug Safety Officer (DSO) / QPPV
Company Address: Takeda Israel Ltd. 25 Efal st. POB 4140 Petach Tikva 4951125 Israel.
Job Holder reports to: Area Lead Drug Safety Officer
Persons reporting to Job Holder: 0-1 PV Staff
Activities and Responsibilities
QPPV is a must legally in order to manage all activities relating to the collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for registered products. He/ She is appointed by the managing director of the company, who applies to the Ministry of Health for their approval and nomination. The QPPV is legally responsible vis a vis the Ministry of Health on any professional matters and issues, relating to the pharmaceutical preparations he/ she is in charge of according to his nomination, All in accordance with Pharmacists Ordinance (new version) - 1981, the Pharmacists Regulation (preparations) –2013 and SOP number 6 of the MOH (adverse events and new safety data reporting) and any other guidelines published periodically by the Ministry of Health. QPPV is also responsible to follow and carry out all activities in line with Takeda guidelines and SOPs.
Key responsibilities of the QPPV:
- Establishes and maintains a local PV system in accordance with local legislation and Takeda requirements
- Handles safety information in Takeda local PV unit (LOC) according to Standards and SOPs
- Works with stakeholders including Global Patient Safety, PV compliance, Quality etc to ensure oversight and management of local compliance, CAPAs, deviations etc.
- Identify potential sources of reporting AE, extract AE data from various and spontaneous sources
- Ensures timely submission of reports (including PSURs, AE reposting) to the MOH in accordance with applicable regulations
- Ensures 24/7 coverage for PV related matters in the LOC, including in public holidays, vacations and in any case which may arise with potential impact on PV activities (Establish Business Continuity Plan)
- Conducts PV training of all LOC staff at all sites within the territory
- Where potential AEs may be reported, ensures PV training of external service providers where a PV task has been subcontracted
- Reviews contracts of external service providers involved in activities where potential AEs may be reported to ensure appropriate PV requirements are included and ensures that local internal procedures are established
- Keeps an oversight about Risk Management Plans (RMP) and risk minimization activities relevant for the territory covered by the DSO
- Provides PV input to applicable organized data collection initiatives (Market Research, Patient Support Programs etc)
Petach Tikva, Israel