Qualified Person Pharmacovigilance (QPPV)

Job description

  Job facts

Job Description:

Ensures that collection, reporting and handling of safety information associated with Roche products is performed according to global Roche and local regulatory requirements.

Maintains oversight of safety risk management and all other pharmacovigilance (PV) activities and ensures PV compliance and inspection readiness across all affiliate functions.

·  Active member of local Drug Safety team ensuring the necessary quality, including the correctness and completeness, of PV data submitted to the Israel health authorities
·  Acts as Roche's Israel contact point for Pharmacovigilance Inspections
·  Management of Individual Case Safety Report (ICSR) from all relevant sources.
·  Ensuring that safety queries, other significant safety issues and crisis management are performed according to global Roche and local regulatory requirements
·  Ensuring that Safety reporting processes are in place
·  Preparing and managing safety reports
·  Collaborates with relevant functions internally to ensure an adequate level of awareness and education of Roche Israel employees, including medical representatives, as regards safety matters, safety data collection and reporting.
·  Oversight of Risk Management Plan Implementation

Requirements:

·  Must: Pharmacist or M.D. license from Israel Ministry of Health.
·  At least 2 years' practical experience in his profession.
·  Experience in Drug Safety and familiarity with relevant regulations (PV)
·  Preferred - experience in the pharmaceutical industry as QPPV or member of PV

function , in Clinical Pharmacy or Clinical Trials

·  Leadership and management skills, excellent team player
·  Organization and planning skills
·  Communication skills
·  Proven ability to interact well in a multifunctional team setting
·  Fluent English and Hebrew knowledge, written and verbal
·  Strategic overview and personal flexibility
·  Proven cross organizational collaboration ability
·  Strong analytical skills
·  Excellent computer skills

·  Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer.