Internal External
The Pharmacovigilance (PV) Officer is required:
o To report spontaneous ICSRS to Suppliers and Health Authority – create hard copy template for the PV Associate to adapt and distribute
o To report Suspected and Unexpected Serious Adverse Reactions to Health Authorities
o To perform ICSR reconciliation with business partners, if required
o To track ICSRs
o To write or contribute to PSURs and ADRs as required. This may include acting as the project coordinator, collating the needed information, incorporate reviewers’ comments and finalizing the document.
o To assist with pharmacovigilance processes, supporting preparation of SOPs, product safety reviews and literature reviews as required.
Technical Responsibilities
o Substantial experience in a PV or compliance related role
o Deep understanding of pharmacovigilance and regulatory requirements.
o Sets high standards and with continuous attention to detail. Is able to operate objectively and independently, deciding when to escalate issues where appropriate
Administrative Responsibilities
o Prepare and review all SOP’s P.V. plan for all our suppliers.
o Collect all the data of ADR’s essential to fill CIOMS forms.
o Fill CIOMS forms and report them to the Principle Company and relevant authorities.
o Represent the company in MOH and different authorities.
o Capable of communication with different suppliers and stakeholders to prepare registration files and P.V. forms.
o Prepare all the registration files to be submitted to MOH for medical, pharmaceuticals and GSL products.
o Provide leadership for the development, management and tracking of quality and compliance checks across the Company at regional and local level to ensure compliance.
o You will be responsible for Quality Control measures
o You will be responsible for the processing of data
o You will be responsible for the product complaint handling
o Provide Trainings to internal departments on PV Procedures and reporting
Job responsibility, skills, team size, reporting, traveling, etc.:
