Fresh Job Openings at Novartis

Job Description

• To meet the strategic objectives of the Medical Affairs department and NOVARTIS (SA) by providing excellent medical expertise and innovative support to both internal and external customers
• Accountable for implementation of local medical product strategy Accountable for the integrity of marketing material which has been passed through the Medical Department Accountable for phase IV/post marketing studies initiated in area of expertise Accountable for representative knowledge in the areas which have been trained by the Medical Manager Accountable for the medical correctness of dossiers prepared by Market Access which have been signed off by the Medical Manager Financial authority limits as agreed with Business Info & Support Manager Safekeeping and maintenance of assigned company propertyPRODUCT & THERAPEUTIC AREA EXPERTISE: Positive feedback from internal / external customers. Brand team meetings attended and valuable contributions to strategy made at IPS (LRR when applicable) sessions. MEDICAL MARKETING: valuable input is given to Marketing to drive strategy throughout a drug's lifecycle; there shouldn't be no justifiable complaints from competitor companies or the Pharmaceutical Manufacturer's Association DRA and MARKET ACCESS SUPPORT: DRA pharmacist should provide positive feedback on assistance given; Dossiers should not be returned with queries which are not covered in the submission (within reason); the feedback from funder meetings regarding presentation quality is positive from both internal and external customers; feedback from market access is positive regarding the review of letters TRAINING and SCIENTIFIC SUPPORT: positive from internal and external customers; field force performance in the areas trained is adequate as judged by customer feedback and internal evaluation. MEDICAL INFORMATION and CUSTOMER SERVICE: no justified complaints from internal and external customers; safety audits should find no discrepancies/omissions in Medical Manager source documents; positive feedback and enhanced relationships with KOL's and advocacy development PHASE IV/PMS STUDIES: clinical trials timelines are met; patient recruitment targets are met; no critical or major data quality/validity flaws should emerge from quality assurance audits CORPORATE GOVERNANCE: compliance with all aspects of the code of conduct/corporate citizenship; corrective action taken where deviation is noted; reporting of non-compliance
• Minimum requirements MBChB or PhD preferred, Postgraduate Science degree or unique combination of degrees as a minimum requirement, Teaching/Training /Clinical Trial Exposure advantagous English Previous industry experience in a Medical Advisor capacity a distinct advantage

Job ID 205454BR

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Job Description

• To support management of Patient Safety operational processes at Country Organization in ensuring compliance with Novartis global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of Novartis group marketed and investigational products (drugs and devices).
• Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.
• Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities and/or clinical operations in cooperation with other Country Organization Departments.
• Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third party contractor, if applicable. 4.Survey and monitor national pharmacovigilance regulations and provide update to global Patient Safety organization.
• Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
• Input, review and approval of program proposals for language, content and establishment of n
• ecessary controls on collection and reporting of adverse event information. 7.Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources. 8.Management and maintenance of all relevant Patient Safety databases. 9.Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.
• Develop and update training materials for pharmacovigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third party contractor, if applicable.
• Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections.
• Manage and maintain efficient Patient Safety filing and archive system.
• Review of all Phase IV Clinical Trial and NIS protocols safety sections and if a Contract Re-search Organization
• Drives the local execution of the RMP for all Novartis group products in (Southern African Countries):

Minimum requirements 2-3 years industry related experience , Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist).

• Fluent in both written and spoken local language
• Knowledge of national and international regulations for pharmacovigilance
• Knowledge of pharmacological and medical terminology.
• Excellent communications, interpersonal and negotiation skills
• Quality and focus oriented
• Computer skills.

Job ID 211453BR

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