Responsibilities :

Represent the affiliate’s medical/scientific voice of expertise for Rx.  The position provides medical, scientific expert advice, guidance to key customers for assigned products and relevant therapeutic areas, including scientific exchange and professional relationship development with key opinion leaders.  It provides medical / scientific input into marketing strategy and key commercial initiatives, as required, and medical / scientific support for medical department activities under the direction of the Head of the affiliate medical function.

• Develop and maintain in depth knowledge for assigned product(s) through participation at key internal meetings/training sessions, relevant congresses, and seminars and by regular self-study of the national/international literature.
• Provide expert medical/scientific advice for assigned products and related therapeutic areas, including responding to requests for scientific/technical information; contribute to the development and medical and scientific accuracy of core dossiers generated by the medical department.
• Establish and maintain professional and credible relationships with key opinion leaders and academic centers; this will involve participating in scientific congresses, coordinating advisory boards, round-table meetings, discussion etc.
• Deliver scientific presentations and medical education programs to healthcare professionals individually or in groups, where requested.
• Screen relevant literature and other information from relevant scientific societies meetings and conferences and develop summaries of key messages for use within the company.
• Review and preparation of promotional material. Ensure the medical/scientific content is correct and fully compliant with the company’s internal policies and guidelines.
• Provide medical/scientific input into marketing strategy and key commercial initiatives, as required. Monitor the environment for competitive intelligence and communicate, where appropriate, within the Company.
• Ensure compliance with all applicable national laws and regulations, guidelines, codes of conduct, company’s policies and procedures and accepted standards of best practice.
• Co-operation on clinical research activities with the global medical activities. Ensure compliance with Corporate and Divisional Standard Operating Procedures SOPs, Good Clinical Practice, and local regulatory requirements pertaining to the conduct of clinical studies.

Support clinical activities by taking responsibility for the design and implementation of local clinical trials, including IIS, feasibility studies and non-interventional clinical research activities; ensure activities are aligned with global strategy. Ensure appropriate local, regional and global review and approval for all affiliate research related activities. Ensure compliance with Corporate and Divisional Standard Operating Procedures SOPs, Good Clinical Practice, and local regulatory requirements pertaining to the conduct of clinical studies

• Ensures local processes and procedures are in place to clearly define pharmacovigilance responsibilities within the Affiliate in line with Global SOPs and local regulations.
• Fulfills all responsibilities of the affiliate Safety Representative such as: SOPs, Compliance, Adverse event processing, Product Complaints, Organized Data Collection Programs, Safety Data Exchange Agreements and other PV Agreements, Training, Audit and Inspections, Risk Management, Safety Monitoring, After Hours Availability

Qualifications: 

• At least a Bachelor of Pharmaceutical Science,
• At least 5 years of experience as medical affairs, MSL, PV representative or CRM/CRA in pharmaceutical companies or CRO,
• Good command of English