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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
Support the PV Operating System
- Ensure that communications from local internal groups (including, but not limited to, sales 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, telephone, etc) to identify ICSRs and other safety information needing reporting to PSPV/Global PV entities, HAs, Partners
- Interaction with global vendor(s)
- Interaction with PSPV when required.
- Support with periodic reports, risk management, signal management, PV contracts, digital projects, patient programs
Major Challenges/Problems:
- In this function, a number of complex tasks has to be managed with very tight deadlines. Regulatory, as well as medical aspects, in combination with internal and external communication need to be handled. Multitasking is necessary every day. Effective problem-solving strategies needs to be identified, implemented, and reviewed on a continuous basis with the CSS.
- The above challenges are effectively managed through strong communication skills paired with an assertive yet collaborative approach, a high level of medical and scientific expertise, integrity, effective time management skills, and dedication to patient safety.
Key Internal and External Relationships:
- PSPV – communication, technical questions
- Medical Advisors and MSLs – consult as relevant to PV responsibilities (e.g.: medical evaluation of PV cases, identification of safety signals, 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
- Regulatory department – communicate the relevant PV responsibilities (e.g. product labelling information, safety queries from relevant HA, PSUR and RMP submission)
- Training managers/HR – matters regarding PV training of all staff
- 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
ABOUT YOU:
JOB-HOLDER ENTRY REQUIREMENTS:
- Pharmacist or Bachelor of Science degree or equivalent (pharmacology or post-graduate qualification will be an advantage)
- Previous pharmacovigilance and regulatory experience will be an advantage
- Knowledge of MS Word, MS Excel(advanced), MS Power Point
- Fluent in English – spoken and written
Behavorial Dimensions Required
- Good communication skills
- Attention to detail
- High focus on quality
- Sense of responsibility
- Respect of confidentiality
- Team player
- Deadline driven
- Ability to prioritize and manage time appropriately
