Drug Safety Responsible

Novartis

Egypt

Ref: NP720-18

Job description / Role

Employment: Full Time

Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care products, cost- saving generic pharmaceuticals, consumer health products, preventive vaccines and diagnostic tools. Novartis is the only company with leading positions in each of these areas.
Novartis OTC (Over- the- Counter) is a word in the research, development, production and marketing of self-care products. Our products are designed for in- home treatment of medical conditions and ailments to help improve people’s ability to live the healthy lives they want for themselves and their families.
At the International level, we have a robust portfolio of cough, cold, respiratory disease treatments, digestive health solutions and pain management medication, as well as skin care products, smoking- cessation therapies and mineral supplements.

Management of the complete Pharmacovigilance process in consistency with national and regional regulations and with Novartis rules and procedures for all products registered/marketed locally, including drugs, medical devices, food supplement, cosmetics.
The jobholder also takes the responsibility for vigilance activities in all countries for which he is responsible for Pharmacovigilance.

Timely processing and submission of AEs to National Competent Authorities
-Global SOPs implemented, local SOPs/Working Instructions are in place as required
-Pharmacovigilance oversight in all countries the jobholder is responsible for.

Maintains and update local pharmacovigilance SOPs and procedures in consistency with national and regional regulations and with NCH procedures. Adherence to NCH global PV SOPs.

Conducting training of local staff (DSP and non-DSP as appropriate, including sales and medical representatives) on pharmacovigilance processes, ensures that CV, role profiles, training plans and training records are accurate

Collecting, assessing, processing (including translation, tracking, reconciliation, quality review) and reporting to National Competent Authorities of adverse event reports for drugs, devices, cosmetics and food supplements according to NCH procedures and National Requirements.

Responsibilities:

Monitoring of National Competent Authorities websites and publications for adverse events as required.

Ensure compliance with PV activities (KPIs for ICSR submission, PSUR submission, etc).

Requirements

2-3 years’ experience in PHV department

Fluent English and French spoken and written (beside Arabic as mother tongue).

Degree in science (medical, pharmacist, biologist, …)

5 years working experience preferably (but no mandatory) in the Pharmaceutical Industry, preferably (but no mandatory) in Drug Safety, preferably (but no mandatory) in adverse event handling, or in a pharmacy/medical practice/hospital, or post-graduation PHD-period or equivalent

About the Company

Novartis UK is the UK affiliate of Swiss-based Novartis AG – one of the largest and most widely respected healthcare companies in the world.

In the UK Novartis employs over 3,000 people across eight sites, including Novartis UK headquarters in Frimley, Surrey. These sites are responsible for research, development, sales, marketing and manufacturing of products used in the UK and worldwide.

Our portfolio focuses on healthcare sectors that are growing rapidly, reward innovation, and enhance the lives of patients. Novartis is the only company with leading positions in each of these key areas:

Pharmaceuticals: innovative patent-protected prescription medicines Alcon: eye care with surgical, ophthalmology and consumer products Sandoz: affordable, high-quality generic medicines and biosimilars Over-the-Counter (OTC): self-medication products that do not require a prescription Vaccines and Diagnostics: vaccines to protect against life-threatening diseases Animal Health: new and better ways to prevent and treat diseases in animals

Our strategy is to provide healthcare solutions that address the evolving needs of patients and societies worldwide.

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