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Assistant Manager - Pharmacovigilance


3 - 4 years United Arab Emirates - United Arab Emirates

Bachelor of Pharmacy(Pharmacy). Any Nationality

, Posted on May 15, 2018 1 Opening

Job Description

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As Assistant Manager - Medical Affairs Department, you will be reporting directly to the Medical Affairs Director for your all assigned activities. You should have department level influence and to lead a team of Pharmacovigilance Specialists and Local Safety Responsible in UAE and other countries. You have to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required Pharmacovigilance legislation. You have to represent Julphar in scientific communities and liaison with Health Authorities.
Key responsibilities & Accountability:
To coordinate directly with Ministry of Health (MOH) of various Middle East - North Africa countries for Pharmacovigilance requirement.
To be able to prepare for health authority audit and presentation.
Safety Data Exchange Agreement writing/reviewing along with Company Legal Department.
Developing in house Pharmacovigilance Team.
Setting up Pharmacovigilance Plan for next three years for the organziation.
To be able to draft SOPs for different process in Pharmacovigilance and its training.
Vendor allocation and management for electronic database and reporting for pharmacovigilance.
Maintenance of PSMF and its approval from various MENA Health Authorities.
Aggregate report writing (PSUR, RMP, ACO, etc.) as required by various Health Authorities.
ICSR processing in Pharmacovigilance Database.
Overall experience for managing a Pharmacovigilance system for a mid-size pharmaceutical organization.
- Education
Bachelor's / Master's Degree in Pharmacy or any equivalence.
- Experience:
Minimum of years' experience in Pharmacovigilance with emphasis of in MENA region is preferred.
MOH UAE approved.
- Training:
- Specialized Knowledge and Skills:
Excellent English language is required with Arabic Language preferred but not mandatory.
Excellent experience in working with Microsoft Office.
Key Competencies:
Accountability Analytical Thinking Building Trust Communicating in Writing Communicating Orally Continual Learning Establishing Focus Flexibility Getting Results Initiative Innovation Interpersonal Skills

Industry Type : Pharma / Biotech / Clinical Research
Functional Area : Administration


Pharma Analytical Pharmacovigilance Pharmacy Auditing Email Manager Medical Affairs Interpersonal skills English language MS Office

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Established in 1980 in the UAE, Julphar Gulf Pharmaceutical Industries is the largest generic pharmaceutical manufacturer in the Middle East and North Africa. Beginning its journey with the first stand-alone facility that produced 5 products, Julphar now operates 15 globally certified manufacturing facilities. Distributing medicines to more than 40 countries globally, the company maintains a broad range of product portfolio that includes categories such as Pediatric Primary Care, Wound, Anemia and Women Care, Cardiopulmonary Care, Consumer Care, Adult Primary Care, Gastro Care and Pain Management. The company holds the vision to be recognized as the leader for pharmaceutical products and contribute to a better healthcare in the Middle East and Africa region.

Julphar’s 13 facilities are based in the UAE while other manufacturing units are available in Bangladesh, Ethiopia and Saudi Arabia as a part of its international expansion plan. In 2012, the company also launched the only one of its kind Active Pharmaceutical Ingredient (API) manufacturing facility in the Middle East named as Julphar Diabetes, which supported its positioning among the largest manufacturers of insulin in the world. Julphar has bagged several awards and ISO9001 and ISO14001 accreditations. It works closely with regulatory bodies, such as the US Food and Drug Administration (FDA) and the UAE Ministry of Health (MOH) to ensure that all their practices are aligned with the international requirements.

Julphar employs around 3,000 people around the world and believes that its corporate results are achieved due to its dedicated employees. Working for Julphar offers an opportunity for career and personal development.

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