Manager - Medical Affairs

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 ICSSRS 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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