PV Scientist (R1124146) in Madrid, ES at IQVIA™

Date Posted: 3/23/2020

Job Snapshot

  • Employee Type:
    JTNS
  • Location:
    Madrid, ES
  • Experience:
    Not Specified
  • Date Posted:
    3/23/2020
  • Job ID:
    R1124146

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Activities to be performed:

Post-marketing (ICSR) handling:

- Managing local safety information collection and transmission to GPS via our electronic case IRT System in English, timely and accurately

-  Perform Follow up of spontaneous ICSRs

98% Compliance of Case transmission to GPS within 48h

95% F/Up queries within 1st week of information received date and programed reminders

Regular Reconciliation to ensure that there is no safety reporting missed from all information entries via:

- Medical Information

- Quality complaints reporting

- PDCS projects as applicable (Patient Data Collection Systems such as Market Research Projects, Digital programs, etc.)

90%

Document Filing (electronic/paper) and preparation of documents for external Archiving

Filing completed as shown by random checks

Patient Data Collection Systems:

- Support Local Patient Safety Officer (LPSO) with PDCS review, preparation of documentation for the certification and closure of the programs  

To be performed on request by LPSO or during her absence

Keeping updated on local PV regulations and comply with the Company’s training requirements

100% training completed on time

Safety information requests from Health Authorities, during LPSO absence: transmission to GPS and ensuring timely submission, interacting with GPS and Local Regulatory

To be performed during LPSO’s absence within established timelines

Local training activities, during absence or by delegation of the LPSO

To be performed on request using established presentations

Local PV System – Support LPSO with
-
Establishing and maintaining the local PV documentation in line with the corporate quality documents and local regulation

- Local medical alert processes
- PV internal audits and health authority inspections

- CAPAs preparation, execution and follow up

To be performed on request by LPSO

Clinical Safety

- Handling and Submission of SUSARs to HAs within established timelines

- DSUR submission to lead ECs (where applicable)

- Maintain filing of submitted clinical trial safety documents

- Forward required safety documentation to Global Patient Safety when requested

98% Compliance of Submission on time

The Vendor Company shall provide an experienced Pharmacovigilance technician who shall perform the described activities according to the Standard Operating Procedures, Policies and Working Instructions.

Literature Search Services

Weekly Local Literature Surveillance

- To review local literature publications not indexed in international databases, on a weekly basis and provide results on the same day of performing the search

- To provide annual confirmation of having reviewed the indexing status in Medline and Embase of local literature sources to ensure there is no duplication of searches with Global Patient Safety.

- To regularly review and determine relevance of current list of literature sources and provide alternative proposals
 

Provide weekly documentation within the first two days of the week.

Provide annual confirmation within one week of performing the review.


The Vendor Company will perform weekly searches of local scientific and medical publications not indexed in Medline or Embase, to detect any possible individual case safety reports (ICSR), special situations (e.g off label, overdose, misuse, drug interactions, utero exposure etc), in connection with the use of any of our medicinal products or active ingredients. In addition, during the search, the Vendor Company will look for any non ICSR safety relevant information of potential interest for product safety surveillance activities and which may impact the benefit risk of any of the clients products.

The results of the search and any detected relevant information will be sent to the client on the same day the search is performed.

The search strings used and list of products will be provided by the clients and included within the weekly search reports provided by the Vendor. The client will inform the Vendor of any changes to the list of products which will need to be implemented on the next due search.

On a yearly basis, the list of publications in use, will be checked against the Embase and Medline indexed journals to confirm that the reviewed local journals remain to be un-indexed in the mentioned databases. The client will be informed about the review and its outcome. If any changes are required, the updated list will be implemented in the next weekly search.

The Vendor will provide experienced and appropriately trained personnel. Upon changes of personnel, the Vendor will inform the client  so that SOP training is performed. For those activities for which the client does not have a procedure in place, the Vendor’s SOPs shall be followed

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.



Job ID: R1124146