In conjunction with the CSLs assures compliance with the GP E / G l obal PV entitie s ‘ policies for Sanofi as well as local PV regulations for assigned countries: The countries that fall under the CSLs responsibilities are: South Afric a , Lesoth o , Swaziland , Namibia, Botswana , Angola , Malawi, Zambia , Zimbabwe , Sao Tome , Cape Verde, Mozam b ique, M a u ritiu s , Guinea B i ssau.
This role further supports, when require d , the larger Multi-Country Safety Organisation as defined in the MCSL Job De s c riptio n .
In this roles it will be expected to take on certain administrative and assistant type responsibilities, such as travel booking, expense submissions etc.
Where needed, the role will be required to get involved in some of the non-routine PV activities, such as market research, patient support programs, digital projects, partner management (PV training and circulating of SDEAs for signature), audit preparation and SOP writing.
In conjunction with the CSLs, this role assists in the responsibility of organising, implementing and maintaining a local PV system – especially with regards to patient support programs.
MAJOR DUTIES & RESPONSIBILITIES:
Take part in Organising a PV Quality System:
Comply with local PV regulations and the global Sanofi group procedures. Assist with the implementation and documentation thereof. Compliance with global procedures will also ensure that the Sanofi entities are in compliance with global PV regulatory o b l igations and commitments.
Responsible for education and training on safety topics within the local organisation are performed in c l u ding documentation of attendees and topics cov e re d . This is applicable to the t r aining of affiliate office based staff as well as other members of staff such as sales representatives , local contractors and local manufacturing sites (ie Annual PV Awareness campaign and sales representatives trai n i ng on pharmacovigilance).
Assist in ensuring timely completion of audit and inspection observations and ensure permanent inspection readiness for PV activities.
Assist with compliance tracking of ICSRs and PSRs.
Alert the CSL or MCSL of any deviation from a global or local process.
Support the PV Operating System:
Ensure that communications from local internal groups (including, but not limited t o , s a l es representatives , medical information, or any other group that has first contact with a reporter) and from external parties about safety information are timeously attended to:
Continuously monitor and review incoming communication (email, tel, fax etc) t o identify ICS R s and other safety information needing repor t i ng to GP E / Global PV entities , HAs, Partners; complete the required reporting forms and generate the required submissions forms and ensure reporting and submissions are done within the stipulated timelines
Local periodic reports are handled appropriately , including PSRs and periodic reviews to comply with GPE/Global PV entities Quality Documents (QDs/SOPs) and local regulatory PV requirements:
Contribute together with GPE/Global PV entities and RA departments to the planning for periodic safety reports
Own the preparation of the South Africa specific summary reports for the HA
PSP case management; tracking and submission
Ensure reporting is in line with timelines stipulated in SDEAs
Ensure queries from partners are addressed timeously
COMPLEXITY & PROBLEM SOLVING
In this function , a n amount of complex tasks has to be managed with very tight deadline s . Regulator y , as well as medical aspects, in combination with internal and external communication need to be handled. Multitasking is necessary every da y . Effective problem solving strategies needs to be identifie d , implemented and reviewed on a continuous basis w i th the CSLs.
The above challenges are effec t i vely managed through strong communication skills paired with an assertive yet collaborative approac h , a high level of med i cal and scien t i f i c expertise, i nteg r i ty, effective time management skill s , and dedication to patient safety .
Key Internal and External Relationships:
GPV – communication, technical questions
Medical Advisors and MSLs – consult as relevant to PV responsibilities ( e . g . : medical evaluation of PV cases, identification of safety signal s , safety aspects of local clinical studies/programs ( e . g Patient Support Programs ) .
Clinical safety officer and delegates – communicate PV responsibilities and ensure clinical study SAE reporting
Reg u l atory department – communicate the r e l evant PV respon s i bilities ( e . g. product labeling informa t i o n , safety que r i es from relevant HA, PSUR and RMP submission)
Training manager s / HR – matters regarding PV training of all staff
HA – review relevant PV responsibilities and comply
Local license partners – communicate PV responsibilities and comply to agreement
Digital department – communicate PV responsibilities
Other assistants – stay abreast with administrative, travel and finance requirements
Legal department – communicate PV responsibilities
Quality department – communicate PV responsibilities and PTCs
Vendor companies – communicate PV responsibilities for PSPs, MR and digital
Decision Making Authority: This po s i tion req u i res decisions to be made together with the direct supervision of the CSL and MCSL.
JOB-HOLDER ENTRY REQUIREMENTS :
MINIMUM SKILLS/EXPERIENCE AND KNOWLEDGE REQUIRED (COMPETENCIES)
Bachelor of Science d egree or equivalent (pharmacology or po s t -graduate qualification will be an advantage )
Previous pharrnacovigilance and regulatory experience will be a n advantage
Knowledge of MS Wor d , MS Exc e l ( adv a n ced), MS Power Point
F l uent in E nglish – spoken and writt e n
Understanding and or exp e r i enced in data privacy
BEHAVIOURAL DIMENSIONS REQUIRED
(EG. MANAGERIAL , COMMUNICATION , ETC.)
Good communication sk i l l s
Attention t o detail
High focus on qu a l i ty
Sense of responsibility
Respect of confident ia l i ty
Ability to prioritize and manage time ap p r o priat e l y
Sanofi IS AN EQUAL OPPORTUNITY EMPLOYER If you are interested in applying for this vacancy and you are confident that you meet the criteria set out in the advertisement kindly click on the link here
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