Pharmacovigilance Associate
Santiago, Chile, 00000
We Are Teva
Our Team, Your Impact
- Core member of the safety team who is responsible for performing Pharmacovigilance (PV) activities within the PV Americas Operations Hub, in partnership with America’s Local PV Units to receive and review Individual Case Safety Reports (ICSRs) information for pre-marketed and post-marketed products in a timely manner, with high quality, and in compliance with worldwide regulatory and Global PV requirements.
- Should serve as a liaison with other Teva business units and function as a resource to the team.
- Review and confirm that accurate written records of all PV related activities are created, organized and maintained in compliance with all applicable global and local Standard Operating Procedures (SOPs), local Work Instructions (WIs) and ensure that they are up to date as required by regulations.
- Support with initiatives to drive end-to-end process efficiency, harmonization, operational excellence, and compliance at local, regional, and global levels.
- Act as a back-up pairs during absences from the office due to vacations, illness, offsite meetings, or attendance at educational events such as seminars/symposia.
How You’ll Spend Your Day
ICSR Handling:
- Responsible for initial intake, pre-triage, registration, duplicate check, promotion, triage and case assignment of ICSRs within the required timeline according to applicable SOPs and WIs.
- Responsible for distribution of ICSRs to relevant partners within the required timeline as per pharmacovigilance agreement.
- Responsible for submission of ICSR to relevant Local Health Authorities (HA) according to regulatory guidelines and within corresponding timelines established in relevant SOPs and WI.
Pharmacovigilance QMS:
- Participate in Pharmacovigilance audits and inspections as needed.
- Responsible for drafting and finalizing CAPAs as needed for late submissions and non-compliance with internal processes.
- Owning, redacting, reviewing and updating SOPs/WIs.
- Responsible for completing all training and SOP/WI reviews in a timely manner.
PV Reconciliation:
- Responsible for performing all assigned reconciliations of ICSR with external and internal partners as required by PV Agreements and relevant SOPs/WIs.
- Establishment and completion of all the necessary actions derived from findings during reconciliation process.
Other tasks as assigned by management
Your Skills and Experience
Education:
- Required: Bachelor of Science (Physics, Chemistry, Biology, Biochemistry, microbiology, physiology, anatomy, pharmacology, etc.)
- Preferred: Rph or RN or Degree in the field of Medicine or Pharmacy or Nursing or equivalent combination of education and related work experience.
Experience:
- Required: 3-5 years of Health care/pharmaceutical industry experience and at least 2 years of Pharmacovigilance experience.
- Preferred: 2 years PV experience.
Specialized Skills or Technical Knowledge Licenses, Certifications Required:
- Demonstrates proficiency with Microsoft Office Word, Excel, Power Point and Adobe Acrobat.
- Knowledge of PV IT systems such as Veeva Vault, ArisG, Argus, Cognos as an added advantage.
Functional Knowledge:
- Comfort with PV IT systems and a familiarity with safety databases and medical terminology.
Company / Industry Related Knowledge:
- Knowledge of the related FDA/Health Canada/LATAM and international regulations.
How We’ll Take Care of You
Reports To
PV Senior Manager
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