Manager - Medical Affairs

Julphar; Ras Al Khaimah; Vor Ort; AED 350.000 - 750.000; Vollzeit

Zusammenfassung

Julphar is seeking a Senior Pharmacovigilance Specialist to serve as the Subject Matter Expert in pharmacovigilance. You will liaise with regulatory authorities, lead audits, and deliver technical trainings to audiences across regions.

The role requires a Master’s in Pharmacy, 10+ years PV experience, and a valid MOHAP QPPV license. You will oversee PV activities, SOPs, SDEAs, and RMPs, ensuring compliance and high-quality safety data handling across Julphar offices.

Qualifikationen

• Must hold a Master’s degree in pharmacy or closely related discipline.
• Minimum of 10 years of progressive experience in Pharmacovigilance.
• Valid MOHAP license as QPPV required.
• Experience developing and delivering PV training programs.
• Strong ability to communicate complex scientific concepts to technical audiences.

Aufgaben

• Serve as SME in Pharmacovigilance.
• Liaise with legal/regulatory health authorities for audits and inspections.
• Deliver training and presentations to technical audiences.
• Oversee PV activities in countries with Local Safety Responsible personnel.
• Support Director with departmental tasks.
• Prepare, review, and analyze PV SOPs.
• Participate in regional Health Authority audits.
• Manage Safety Data Exchange Agreements (SDEAs).
• Oversee Risk Management Plans (RMPs) and reactive compliance.
• Perform MedDRA coding for ICSRs; manage PV vendors.
• Coordinate local and global literature surveillance.
• Oversee intake, processing, and submission of ICSCRs in relevant countries.
• Conduct PV training for students and Julphar staff.
• Define org structure for PV efficiency and communication.
• Review compliance with PV policies and procedures.

Kenntnisse

Leadership

Regulatory compliance

Auditing

Training delivery

Cross-functional collaboration

Communication

Analytical thinking

Decision making under pressure

Problem solving

Ausbildung

Master’s degree in Pharmacy

Tools

MedDRA coding

Jobbeschreibung

Job Description:

At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.

Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world‑class research and with the compassion and commitment of our employees.

Detailed Job Description

• Serve as the Subject Matter Expert (SME) in Pharmacovigilance.
• Liaise with legal and regulatory health authorities, facilitating pharmacovigilance related audits and inspections.
• Deliver training and presentations to highly technical and scientific audiences.
• Provide oversight of pharmacovigilance activities in countries where Julphar has scientific offices with Local Safety Responsible (LSR) personnel.
• Support the departmental management team on various tasks as requested by the Director.
• Prepare, review, and analyze Julphar’s Pharmacovigilance Standard Operating Procedures (SOPs).
• Participate actively in regional Health Authority audits.
• Manage Safety Data Exchange Agreements (SDEAs) between Julphar and business partners.
• Oversee Risk Management Plans (RMPs) for Julphar products, applying reactive approaches in accordance with Health Authority requirements.
• Perform MedDRA coding for Individual Case Safety Reports (ICSRs).Manage end‑to‑end pharmacovigilance service vendors to ensure quality and compliance.
• Coordinate and monitor local and global literature surveillance activities.
• Oversee the intake, processing, and submission of ICSSR in relevant countries.
• Conduct pharmacovigilance training for students from various universities following the Julphar Training Centre schedule.
• Train Julphar staff through online platforms regarding pharmacovigilance responsibilities and compliance.
• Define and recommend an optimal organizational structure to ensure efficient resource utilization and effective communication within the pharmacovigilance function.
• Review and ensure compliance with operational and administrative policies, procedures, and practices across the pharmacovigilance division.

Core Competency

• Demonstrates a strong results-oriented mindset, with a high level of accountability, ownership, and commitment to achieving strategic objectives.
• Possesses an analytical and forward-thinking approach, with the ability to see the broader organizational vision and align daily practices with Julphar’s core strategies and transformational goals.
• Quick to grasp new and complex issues, with a proven ability to make sound decisions under pressure. Inspires confidence, fosters trust, and effectively leads and motivates teams.
• Skilled in aligning resources and managing cross-functional teams to deliver impactful results.
• Embraces an open, collaborative leadership style and thrives in an environment that encourages idea‑sharing, innovation, and constructive challenges.
• Exceptional communication, interpersonal, presentation, and decision‑making skills.
• Maintains a solution‑oriented mindset, capable of resolving issues efficiently and within defined timelines.
• Strong presentation skills, with the ability to convey complex concepts clearly, accurately, and concisely to varied audiences.
• Builds and maintains strong, cooperative relationships with department heads and cross‑functional stakeholders.
• Brings hands‑on experience in regulatory audit inspections, including those conducted by US‑FDA, EMEA, and MHRA, specifically in the context of Pharmacovigilance compliance.

Qualification/Functional Knowledge

• Master’s degree in pharmacy or a closely related discipline.
• Minimum of 10 years of progressive experience in Pharmacovigilance.
• Prior experience in a similar role is essential to ensure an effective and seamless transition into the position.
• Must hold a valid MOHAP license as a Qualified Person Responsible for Pharmacovigilance (QPPV).
• Demonstrated experience in developing and delivering Pharmacovigilance training programs.
• Strong ability to communicate complex scientific and technical concepts effectively to highly specialized and technical audiences.

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