Pharmacovigilance Analyst

CORE RESPONSIBILITIES

Adverse Event Processing:

- Responsible of collecting recording, processing, conducting follow up, translating and filing of adverse events (AE) and other safety information reportable to PPS from spontaneous and solicited sources according to local and international requirements, in accordance to applicable SOP/Guideline
- In collaboration with pharmacovigilance team, as per assigned local literature articles, conduct the review, as detailed in the Global SOP.
- In collaboration with pharmacovigilance team, conduct local QC, as detailed in the Global SOP.
- Ensure reconciliation of cases as per Global procedure

ADDITIONAL RESPONSIBILITIES:

- Support pharmacovigilance team in ensuring compliance of affiliate PV quality system.
- Support pharmacovigilance team in ensuring Organized Data Collection Programs are conducted in compliance of PV requirements.
- Support pharmacovigilance team in affiliate and third partner company staff pharmacovigilance training administration as per applicable procedures.
- Support pharmacovigilance team in aggregate safety reporting activities.
- To undergo training relevant to the function and to be familiar and updated with the AbbVie local and international procedures relevant to the Job Description
- Affiliate medical, regulatory affairs, quality assurance and customer service personnel.
- Pharmacovigilance and Patient Safety and International Pharmacovigilance Operational Excellence (IPEx).
- Healthcare Practitioners, consumers and patients.