Pharmacovigilance Graduate

Full job description

ABOUT THE JOB:

JOB PURPOSE:

In conjunction with the Country safety specialist (CSS) assures compliance with the GPV/ Global PV entities' policies for Sanofi as well as local PV regulations for assigned countries: The countries that fall under the CSS responsibilities are South Africa, Lesotho, Swaziland, Namibia, Botswana,

In this role it will be expected to take on certain administrative responsibilities, such as travel booking, expense submissions, filing, archiving etc.

Where needed, the role will be required to get involved in some of the non-routine PV activities, such as market research, patient programs, clinical trials (PV-specific input), managed access programs, digital projects, partner management (PV training and circulating of SDEAs for signature), audit preparation and SOP writing.

KEY ACCOUNTABILITIES:

In conjunction with the CSS, this role assists in the responsibility of organising, implementing and maintaining a local PV system

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 obligations and commitments.

Assist in ensuring timely completion of audit and inspection observations and ensure permanent inspection readiness for PV activities.

Assist with compliance tracking

Alert the CSS and Country Safety Head of any deviation from a global or local process.

Support with PV training, quality document preparation, deviation management

Industries: Pharmaceuticals

Function: Others