Key Performance Outputs<\/p>\n
Organize, manage, and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity.<\/p>\n
\uf0d8 Carry out all case management activities as appropriate.
\n\uf0d8 Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested
\n\uf0d8 Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios
\n\uf0d8 Ensure complete and timely forwarding of ICSR to Core
\n\uf0d8 Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed.
\n\uf0d8 Consistently apply regulatory requirements and Pfizer policies
\n\uf0d8 Analyze and monitor activities, define and implement corrective actions, where applicable.
\n\uf0d8 Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database.
\n\uf0d8 Provide oversight and team mentoring on case handling aspects, data extraction, and analyses.
\n\uf0d8 Manage, where applicable, safety resources in the local team
\n\uf0d8 Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and\/or project lead across all WSRO DSU
\n\uf0d8 Act as subject matter expert for the DSU within WSRO
\n\uf0d8 Act as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners (e.g., BUs, License Partners) regarding safety data collection and handling
\n\uf0d8 Promote\/participate, as appropriate, in local, internal and external safety activities
\nReporting Structure Reports to the Country Safety Lead<\/p>\n
<\/p>\n
Minimum Requirements<\/strong><\/p>\n Degree or equivalent in Science\/pharmacy <\/p>\n Technical Skills <\/strong><\/p>\n \uf0d8 Ability to independently solve routine problems related to case processing and surface issues constructively <\/p>\n Behavioural Skills and Attributes <\/strong><\/p>\n Acts Decisively [button link=”http:\/\/careers.pfizer.co.za\/candidateapp\/Handlers\/GoTo.ashx?Page=ViewJob&JobRef=081013-1¶ms=ovLg2jjkKuDNJgH7A8EOXKCgUqgfxWb9GBZ1Y7L1fi5fnr5Ua7qodaQq3kyxkDnF3tvh6sB0X8uIA9Q5IktvNmpy88FJ6XpEO5D%2f%2baimAw6g2wkxFPS370YdsD%2fdbuNWVAkAE%2fPiAdI0wMPsqhnAnwVm6Ii6yycy” color=”lightblue” newwindow=”yes”] Click here to apply online[\/button]<\/p>\n","protected":false},"excerpt":{"rendered":" Key Performance Outputs Organize, manage, and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by…..<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_newsletter_tier_id":0,"footnotes":"","jetpack_publicize_message":"","jetpack_is_tweetstorm":false,"jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","enabled":false}}},"categories":[56],"tags":[1997],"jetpack_publicize_connections":[],"yoast_head":"\n
\n\uf0d8 Health Care Professional or equivalent experience preferred
\n\uf0d8 Minimum 4 years\u2019 experience in pharmacovigilance and\/or data management, clinical care, or clinical or scientific research required
\n\uf0d8 Experience and skill with medical writing an advantage
\n\uf0d8 Fluency in spoken and written English<\/p>\n
\n\uf0d8 Ability to make decisions independently in both routine case processing and unique and\/or complex situations, and to resolve issues appropriately to achieve a desired result or impact
\n\uf0d8 Ability to discern when additional input is required to effectively address unique and\/or complex situations
\n\uf0d8 Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals
\n\uf0d8 Ability to work independently to accomplish team goals with minimal supervision
\n\uf0d8 Demonstrated ability to foster teamwork
\n\uf0d8 Understanding and ability to use computer technology, management of relational database systems, including extraction of data
\n\uf0d8 Solid working knowledge of pharmacovigilance concepts
\n\uf0d8 Solid knowledge of national and international regulations
\n\uf0d8 Solid understanding of medical terminology
\n\uf0d8 Solid knowledge of global regulations and guidelines for drug development<\/p>\n
\nSeizes accountability
\nChange Agile
\nGrows slef
\nSelf awareness
\nPeer relationships
\nCommits to One Pfizer
\nOther Information This is a six month contract position<\/p>\n