SUMMARY:
Pharmacovigilance (PV) Learner
- Roodepoort/West Rand -
POSITION INFO:
Ideal Candidate:
ØPharmacy, Nursing, HCP or life-sciences degree (or equivalent).
ØDemonstrated attention to detail.
ØExcellent written and spoken communication and presentation skills.
ØFluency in written and oral English is highly desirable in order to facilitate communications with Pharmacovigilance and Patient Safety, Regional Medical and other headquarters functions.
ØHigh customer orientation.
ØAbility to prioritise and work to strict timelines on a daily basis.
ØGood knowledge of relevant Pharmacovigilance legislation and best practices.
ØGood understanding of medical concepts.
ØExcellent verbal and written communication with internal and external customers.
ØAbility to work effectively as a member of the Pharmacovigilance team and broader Medical Department.
Critical Success Factors:
ØBuilds and maintains strong relationships with non-affiliate colleagues.
ØLearns fast, grasps the “essence” and can change course quickly where indicated.
ØActs consistently with the companies ethics, obligations and local laws.
ØFocused on compliance; identifies, manages and escalates issues in a timely manner.
Adverse Event Reporting:
ØFollow local processes, procedures and systems that are in place for recording, processing, conducting follow up and translating adverse events and other safety information reportable to PPS from spontaneous and solicited sources, including Organised Data Collection and SAEs from clinical studies.
ØManaging, triaging and prioritising all information received into the Inbox as required.
ØReviewing ICSR data for completeness and identifying any additional information required.
ØEnter data accurately into electronic dataset as per local and global procedures.
ØManaging assigned reconciliation procedures with other departments or companies to monitor and ensure that all adverse event reports have been received and appropriately processed.
ØRequesting additional follow up information from multiple sources.
ØMonitoring and assessment of reportability of individual Case Safety Reports.
ØEnsures that patient confidentiality and privacy in accordance with local applicable laws and regulations are adhered to and if necessary, performed by redaction of patient information from Adverse Event Forms, medical records i.e., discharge summaries, physician notes, laboratory data information, etc. before information is transmitted to PPS.
NB! This job is now closed. You can apply for other jobs by uploading your CV.
