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 systemTake 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 xe2x80x93 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 xe2x80x93 communicate PV responsibilities and ensure clinical study SAE reporting
• Regulatory department xe2x80x93 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 xe2x80x93 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

PLAY TO WIN BEHAVIORS

• Push to go beyond the level we have operated until now:

constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what wonxe2x80x99t: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment. * Put the interest of the organization ahead of own of those of his her team:consider both short- and long-term impact of decisions; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate level. * Act in the interest of our patients and customers:actively engage with customers to know their current and future needs; brings an external perspective into decisions. * Take action and donxe2x80x99t wait to be told what to do:take smart and informed best bets with the information at hand and anticipate the consequences of her/his actions; use personal judgement and othersxe2x80x99 advice to make bold and impactful decisions which move us forward.Pursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesnxe2x80x99t happen without people xe2x80x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, letxe2x80x99s be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status.Watch our and check out our Diversity Equity and Inclusion actions at !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 below.#LI-AFRPursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesnxe2x80x99t happen without people xe2x80x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, letxe2x80x99s be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at !

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