Qualified Person for Pharmacovigilance

4 weeks ago

Riyadh, Saudi Arabia Ray Full time

Job Requirements:
1-Bachelor Degree of Pharmacy or Medicine.

2-Saudi Nationality

3-Basic training in epidemiology and biostatics and should be licensed by Saudi commission for health specialties

4-Previous Experience in the Pharmacovigilance duties and local PV regulations is required

Job Responsibilities:
1. Availability 24/7 and residing in KSA
2. Serves as Point of contact for the Regulatory authorities on behalf of the contracting MAH and responding promptly to any request from the regulatory authorities.
3. Have access to RAY PSMF and performing its updates and have sufficient authority to ensure its compliance to the regulations
4. Ensuring the necessary quality, including the correctness and completeness of the pharmacovigilance data submitted to the SFDA
5. Handle and process as applicable all spontaneous and solicited safety reports as ICSRs for contracting MAHs and regulatory obligations and submitting them as per regulatory timelines
6. Perform regular Reconciliation with the concerned departments in the contracting MAHs or internally with other RAY departments
7. Management of safety and product complaints reports received by patient support programs, Reconciliation and quality check
8. Handling medical information requests and product defects either associated with AE or not about the contracting MAHs’ products
9. Manage preparation and Submission of PBRERs and their national appendix and addendum to clinical overview, as applicable, according to the regulatory obligations and timelines for contracting MAHs’ products
10. Review and manage safety communication for the concerned audience
11. Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals);
12. Help contracting MAHs’ regulatory personnel in preparation and Submission of Safety Variations, as applicable, according to the regulatory obligations and timelines
13. Prepare for audits/inspections from regulatory authorities or contracted MAH in the department or internal audits for the department to ensure compliance with company and regulatory obligation.
14. Interact with different contracting MAH’s Departments as applicable for integrating PV system (eg. Medical Information, Regulatory Affairs, Product Quality, Clinical Development, Sales and Marketing, Patient support Programs and Quality Assurance)
15. Has oversight over SDEAs with partners and PV database operations and its validation
16. Responsible for regulatory intelligence of the PV regulations in requested countries

**Job Types**: Full-time, Contract

Ability to commute/relocate:

- Riyadh: Reliably commute or planning to relocate before starting work (required)

  • Qualified Person for Pharmacovigilance

    2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Ray Full time

    Job Requirements:1-Bachelor Degree of Pharmacy or Medicine.2-Saudi Nationality3-Basic training in epidemiology and biostatics and should be licensed by Saudi commission for health specialties4-Previous Experience in the Pharmacovigilance duties and local PV regulations is requiredJob Responsibilities:Availability 24/7 and residing in KSAServes as Point of...

  • Associate- Qualified Person for

    2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • (Internship) Associate- Qualified Person for

    2 weeks ago

    Riyadh, Saudi Arabia Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Pharmacovigilance (Pv) Manager Ksa

    3 weeks ago

    Riyadh, Saudi Arabia Vertex Pharmaceuticals Full time

    Job Description Pharmacovigilance (PV) Manager is responsible for maintaining Vertex’s compliance with global Pharmacovigilance regulations for International region. The Manager role works with a high degree of independence and is proficient at troubleshooting problems to create and execute improved internal procedures. By virtue of their experience, the...

  • International Pharmacovigilance Network Senior

    2 weeks ago

    Riyadh, Saudi Arabia Vertex Pharmaceuticals Full time

    Job Description The Saudi Arabia Deputy RPPV maintains currency with evolving local guidance and regulations for PV. This individual supports International PV to ensure GPS has standards and processes in place to meet PV requirements at the local level. By virtue of their experience, the Senior PV Specialist is expected to provide guidance and leadership...

  • International Pharmacovigilance Network Senior

    2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Vertex Pharmaceuticals Full time

    Job DescriptionThe Saudi Arabia Deputy RPPV maintains currency with evolving local guidance and regulations for PV. This individual supports International PV to ensure GPS has standards and processes in place to meet PV requirements at the local level. By virtue of their experience, the Senior PV Specialist is expected to provide guidance and leadership and...

  • Qppv & Local Safety Officer Ksa

    2 weeks ago

    Riyadh, Saudi Arabia Johnson & Johnson Full time

    **The Johnson & Johnson Family of Companies**: A global leader in health and personal care, with over 125,000 employees in over 275 companies in 60 countries. We work with healthcare partners to touch the lives of more than a billion people every day worldwide. “By caring, one person at a time, we aspire to help billions of people live longer, healthier,...

  • Local Medical Safety Specialist, Deputy Qppv Ksa

    3 weeks ago

    Riyadh, Saudi Arabia Johnson & Johnson Full time

    Johnson & Johnson Pharmaceutical is recruiting for **Local Medical Safety Specialist **to be located in **Riyadh, Saudi **. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and...

  • Qppv & Local Safety Officer Ksa

    2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Johnson & Johnson Full time

    The Johnson & Johnson Family of Companies:A global leader in health and personal care, with over 125,000 employees in over 275 companies in 60 countries. We work with healthcare partners to touch the lives of more than a billion people every day worldwide."By caring, one person at a time, we aspire to help billions of people live longer, healthier, happier...

  • Senior Manager, Head of Patient Safety,saudi Arabia

    4 weeks ago

    Riyadh, Saudi Arabia Bristol Myers Squibb Full time

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Local Safety Officer Saudi Arabia

    2 weeks ago

    Riyadh, Saudi Arabia CSL Behring Full time

    **Responsibilities**: The Local Safety Officer is responsible for the Pharmacovigilance System(s) in Saudi Arabia. LSO holds responsibility for fulfillment of local PV regulations and obligations following international requirements and CSLB processes under the guidance of GCSP Regions and in collaboration with contracted 3rd parties. - Regulatory...

  • Senior Manager, Head of Patient Safety,saudi Arabia

    2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Bristol Myers Squibb Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Personal Trainer

    1 week ago

    Riyadh, Saudi Arabia gofitjobs Full time

    **6,000 SAR basic + realistic monthly commission 15k to 20k**: - ** Housing allowance included within the basic salary**: Our partner is a premium operator with world class male and female facilities in Riyadh, and we are delighted to support their latest recruitment drive for experienced and qualified Personal Trainers for their female branch. - The gym...

  • Personal Trainer

    2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia gofitjobs Full time

    6,000 SAR basic + realistic monthly commission 15k to 20k: Housing allowance included within the basic salary:Our partner is a premium operator with world class male and female facilities in Riyadh, and we are delighted to support their latest recruitment drive for experienced and qualified Personal Trainers for their female branch. The gym itself is highly...

  • Personal Trainer

    1 week ago

    Riyadh, Saudi Arabia gofitjobs Full time

    **6,000 SAR basic + realistic monthly commission 15k to 20k**: - ** Housing allowance included within the basic salary**: Our partner is a premium operator with world class gym and wellness facilities in Riyadh, and we are delighted to support their latest recruitment drive for experienced and qualified Personal Trainers for their female branch. - A degree...

  • Personal Trainer

    2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia gofitjobs Full time

    6,000 SAR basic + realistic monthly commission 15k to 20kHousing allowance included within the basic salaryCandidates must already be in Saudi Arabia Our partner is a premium operator with world class gym and wellness facilities in Riyadh, and we are delighted to support their latest recruitment drive for experienced and qualified Personal Trainers for their...

  • Female Pilates Reformer Personal Trainer

    3 weeks ago

    Riyadh, Saudi Arabia FHC-Global Full time

    We are looking for an experienced **Personal Trainer **who is **Pilates Reformer qualified for a prestigious Health Club in Riyadh.** Qualified in any other group classes HIIT, Les Mills, Yoga, Pre/post natal, spinning etc is beneficial. Extremely attractive expat package Housing allowance, transportation allowance, medical insurance, travel ticket, 30-day...

  • Personal Trainer

    4 weeks ago

    Riyadh, Saudi Arabia gofitjobs Full time 6,000 - 20,000

    6,000 SAR basic + realistic monthly commission 15k to 20kHousing allowance included within the basic salaryCandidates must already be in Saudi Arabia Our partner is a premium operator with world class gym and wellness facilities in Riyadh, and we are delighted to support their latest recruitment drive for experienced and qualified Personal Trainers for...

  • Associate Director, Pv Lead

    2 weeks ago

    Riyadh, Saudi Arabia MSD Full time

    The associate director, Pharmacovigilance (PV) Lead reports to the Middle East Cluster PV Lead and is responsible for adverse event management including aggregate and individual case safety report health authority submissions, compliance monitoring and all PV activities are conducted in compliance with local laws and regulations, company policies and...

  • Specialist Personal Trainer

    2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia gofitjobs Full time

    8,500 to 10,000 SR per month base salary + commission: Company AccommodationOur partner is a new and exciting female-only fitness studio offering exceptional facilities and services within the burgeoning and fast-paced Riyadh fitness scene. Led by a highly successful entrepreneur, we have been tasked to help find specialist trainers who will lead the team...