Pharmacovigilance Pharmacist

Do you have the following qualities:
 
1. Strong interpersonal and communication skills
2.A positive attitude towards teamwork and customer focus,
3. Leadership skills
 
WHAT IS REQUIRED OF YOU:
    • B PHARM 
    • A minimum of two (2) year’s work experience in a similar position within the Pharmaceutical industry
    • Working knowledge of GMP and safety standards
    • Strong communication skills, written and verbal.  
    • Proven ability to ‘self-start’ and organise a complex workload and work to strict deadlines  
 
Key Responsibilities:
 
    • Ensure that all adverse event reports are timeously reported to the relevant HA
    • Ensure all/any other safety documentation are timeously reported to the relevant HA and MAH
    • Ensure that all employees are appropriately trained in the identification, collection and reporting of adverse event reports
    • Assist in translation of PIs, PILs and other forms of artwork prior to printing
    • Prepare medical assessments in risk assessments for critical/ major incidents as required.
    • Receive, record and process customer complaints, assist in the investigation, preparation of investigation report, CAPA assignment and implementation and trending of both customer complaints and AEs
    • Ensure up-to-date SOPs for the management of all legal PV and related requirements
    • Ensure that an up to date DDPS document is maintained, and the continuous review of all PV related activities and requirements
    • Ensure that all local scientific literature is timeously reviewed for possible adverse events relating to own and customer products
    • Oversight of Marketing Activities with special reference to Patient Orientated Programs, ensuring that any possible program initiated by/via the marketing department is reviewed and appropriate measures are in place to collect any possible adverse event reports
    • Ensure that agreements that outline the PV responsibilities for each product and requirements are in place and adhered to
    • Ensure timeous submission of reconciliation documentation to all contractual partners in accordance with the contractual agreements
    • Ensure that new guidelines are monitored and implemented on site as per SAHPRA, WHO, ISOand PICS guidelines through creation, update of SOPS and training of staff
    • Monitor CEP status of all API suppliers on EDQM website and keep the vendor list current
    • DMF requests and review of processes to ensure current registrations valid and no non- compliances with regards to related substances, NDMA etc.
    • Ensure all staff are trained and refresher training conducted annually on AE and customer complaint reporting  
    • Participate in self inspections as lead / support auditor  



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