Associate Director, Pv Lead

1 week 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 procedures.

The PV Lead is the primary point of contact for the local Health Authority and serves as the local Qualified Person for PV (QPPV) for Saudi Arabia and ensures a back-up as required per Saudi Arabian PV legislation.

The PV Lead interacts with the Managing Director, Global Clinical Trial Operations, Regulatory Affairs International, Global Medical and Scientific Affairs, and other business unit colleagues in their residing country and supported countries (as applicable) to ensure alignment on matters impacting PV. The PV Lead may be a part of the local leadership team and is a member of the local Medical Governance Council and may undertake additional activities/special projects as assigned.

**Education**:

- The Saudi QPPV must be Saudi Nationality based in Saudi Arabia with a minimum of bachelor degree of Pharmacy or medicine.

**Work Experience**:

- At least 5 years of experience in the pharmaceutical industry with a specific focus on safety and pharmacovigilance related activities
- Experience supervising/managing people is preferred.
- Strong leadership, communication, decision making, and problem-solving skills.
- Detailed knowledge of Adverse Events reporting requirements, relevant PV regulations and PV quality management systems
- Experience with PV audits and/or PV Health Authority Inspections.

**Job-specific competencies & skills**:

- Must be fluent in English (written and spoken) while proficient in local language.
- Ability to travel within the region and globally.
- Excellent interpersonal communications, organizational, and presentation skills
- Excellent negotiation and influencing skills.
- Ability to work in partnership with others (internally and externally) to accomplish quality goals.
- Demonstrates skills to drive change that enhances processes within the company or cross-functionally that improve quality and /or add value to the business.
- Demonstrates strong strategic thinking and project management skills including prioritization of tasks.

**Secondary** Language(s) Job Description**:
رئيس و مسؤل التيقظ الدوائي يقدم تقاريره إلى رئيس التيقظ الدوائي في الشرق الأوسط وهو مسؤول عن إدارة التيقظ الدوائي بالمملكه العربية السعوديه بما في ذلك تقارير السلامة الكلية والفردية للحالات المقدمة من الهيئات الصحيه ومراقبة الامتثال وجميع انشطة التيقظ الدوائي ان يتم إجراؤها وفقًا للقوانين واللوائح المحلية ،و سياسات وإجراءات الشركة

يعتبر رئيس التيقظ الدوائي هو نقطة الاتصال الأساسية لهيئة الغذاء و الدواء السعودية المحلية ويعمل كشخص مؤهل محلي للمملكة العربية السعودية ويضمن دعمًا احتياطيًا كما هو مطلوب وفقًا للوائح التيقظ الدوائي في المملكة العربية السعودية

يتفاعل رئيس التيقظ الدوائي مع المدير العام ، ومسؤلون التجارب السريرية العالمية ، والشؤون التنظيمية الدولية ، والشؤون الطبية والعلمية العالمية ، وزملاء وحدة الأعمال الأخرى في بلدهم المقيم والدول المدعومة (حسب الاقتضاء) لضمان التوافق

في الأمور التي تؤثر على التيقظ الدوائي. قد يكون رئيس التيقظ الدوائي جزءًا من فريق القيادة المحلي وهو عضو في مجلس الحوكمة الطبية الداخلي للشركه وقد يطلب منه أنشطة إضافية / مشاريع خاصة كما يتم تعيينها

:تعليم
- رئيس و مسؤل التيقظ الدوائي يجب أن يكون سعودي الجنسية ومقره في المملكة العربية السعودية مع حد أدنى من درجة البكالوريوس في الصيدلة أو الطب

:خبرة في العمل
- لديك خبرة لا تقل عن 5 سنوات في مجال صناعة المستحضرات الصيدلانية مع التركيز بشكل خاص على الأنشطة المتعلقة بالسلامة واليقظة الدوائية
- يفضل ان يكون لديك خبرة في الإشراف على / إدارة الموظفين
- لديك مهارات قوية في القيادة والتواصل واتخاذ القرار وحل المشكلات
- لديك


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