The Medical Manager will be responsible for overseeing medical affairs, compliance, pharmacovigilance, and quality-related activities within the company. This role is critical for ensuring that all operations are in alignment with regulatory standards and industry best practices.
Medical Compliance: Ensure all medical and promotional materials, communications, and activities comply with local and global regulations and ethical standards. Conduct periodic audits and reviews to maintain compliance.
Pharmacovigilance: Oversee pharmacovigilance activities, including adverse event reporting, monitoring, and safety signal detection. Work closely with the regulatory and safety teams to ensure timely and accurate safety data reporting.
Quality Assurance: Collaborate with the Quality team to ensure all medical processes and documentation meet quality standards and regulatory requirements. Lead quality improvement initiatives and ensure continuous adherence to industry standards.
Stakeholder Engagement & Training: Serve as a trusted medical advisor to both internal and external stakeholders, providing scientific support and training. Lead the development of training programs for sales, marketing, and clinical teams to ensure alignment with medical and compliance guidelines.
Medical Affairs: Support clinical research and medical information functions, providing input on study designs, data analysis, and publications. Act as a scientific expert in cross-functional teams to guide medical strategy and enhance product understanding.
Documentation & Reporting: Maintain and manage accurate records of medical, compliance, and safety-related activities. Prepare and present reports on medical and pharmacovigilance findings to senior leadership.
Make a Meaningful Impact on Patient Safety and Compliance|Grow in a Cross-Functional, Innovative Environment
Education: Medical degree (MD) or advanced degree in a relevant field (PharmD, PhD) is required.
Experience: At least 5 years in a medical affairs role within the pharmaceutical industry, with significant experience in quality and compliance management.
Skills:
Comprehensive knowledge of regulatory requirements, including pharmacovigilance and quality standards in the pharmaceutical sector.
Proven experience in developing and implementing compliance programs and quality assurance processes.
Strong analytical and communication skills, with the ability to work effectively across departments.
Excellent organizational skills and attention to detail, especially in documentation and reporting.
The company is a global pharmaceutical company well established in the region and acting in speciality care.Competitive Compensation & BenefitsProfessional Development & Career GrowthSupportive & Collaborative Work EnvironmentImpactful Work in Patient SafetyFlexibility & Work-Life Balance