PV Specialist - Specialist farmacovigilenta
Middle (2-5 years), Senior (5-10 years)
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.
For our team in Bucharest we are looking for a PV Specialist.
Fulfil the responsibility for the execution of all aspects of pharmacovigilance (PV) in the area of responsibility to ensure that all of AbbVie’s statutory and ethical responsibilities are met.
Adverse Event Reporting:
- Ensures comprehensive data collection and follow-up (. lot/batch #, age or age group, medically relevant information) for all case types and from all potential sources.
- Implements an appropriate local QC procedure to ensure quality of cases submitted and of reporting decisions to local regulatory authority.
- Maintains a version-controlled training matrix/plan for local PV personnel which includes but is not limited to Local SOPs, Local Regulations and references to the Global Affiliate PV Modules in ISOTrain.
- Ensures training compliance with Global and Local PV training requirements in ISOTrain and other mandatory training as required by PPS AVE.
- Ensures training of Affiliate personnel on relevant PV responsibilities is undertaken on at least an annual basis; that appropriate training records are maintained.
- Ensures evidence of compliance related to this training is available to PPS upon request.
- Ensures that any training of partner company staff is completed according to local contract requirements, and appropriately documented.
Reconciliation of Safety Data
- Completes AE reconciliation with all applicable partners and ensures AE identification effectiveness sampling consistent with global procedures.
Quality System / Standard Operating Procedures (SOPs):
- Ensures local processes and procedures are in place to clearly define PV responsibilities within the Affiliate in line with Global SOPs and local regulations.
- Ensures compliance with all Local, Regional and Global SOPs
- Ensures reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic Reports to the Regulatory Authority and Ethics Committees as required.
- Ensure knowledge of and compliance with all Local and European safety regulations, advising Global and European Pharmacovigilance of any changes to Local regulations in a timely manner.
- Medical/Pharmacy /life science degree;
- Minimum of 2 years’ experience/other relevant involvement in PV projects at Affiliate level
- Excellent written and spoken communication and presentation skills.
- Fluency in written and oral English is essential to facilitate communications with Pharmacovigilance and Patient Safety, Regional Medical and other headquarters functions.
- High customer orientation
- Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity