Job
Description
The role of the Medical Office is to bring medical/scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: medical affairs, medical compliance, patient safety, clinical development and post marketing research and medical operations. This entails engaging and collaborating with healthcare organizations, healthcare professionals and customers both internal and external - and generating and communicating relevant, meaningful, and impactful data. What You ll Do: Work actively in risk management activities, including risk management plans, referrals, signal detection and medical writing to support product safety reviews and clinical evaluations. Work actively in identifying and processing signals for all ADVANZ PHARMA products as been assigned within the stipulated time. To prepare Signal reports (including PAS, DSR, SAR as applicable) and maintain the compliance and quality of signal detection. Act as a Safety contact point on all matters relating to Safety agreements with license business partners including the handling of confidential information and negotiation of the agreements with commercial and co-development partners. Coordinate the preparation and conclusion of SDEAs together with relevant internal and external parties. Track and maintain oversight on all assigned Safety agreements. To update SDEAs on a regular basis, coordinate in the completion of business partner responsibility tracker, to identify gaps in the templates and process, make appropriate changes if required. Act as a key contact point on all matters relating to SDEAs with internal stakeholders (e.g. Safety, Quality, Regulatory, Business Development, Supply, Commercial, Legal) as well as external business partners. Actively coordinate with all the internal and external stakeholders to ensure Pharmacovigilance and regulatory compliance. Involvement in pre and post action arising from PV audits and inspections Keeping abreast of changing PV requirements globally. Contribute towards continued improvement of safety systems and processes. Ensure all documentation is structured and maintained as required. Compliance with GPvP and company requirements, demonstrated through audits and inspections. Perform regulatory intelligence activities. Thrive in an entrepreneurial environment and take accountability for results. Embrace challenge and change, applying a growth mindset approach. Have a bias for action and fast decision making. Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity. Drive the spirit of One Team by working collaboratively across all business functions with an open, honest, and respectful cooperation. Contribute to making ADVANZ PHARMA a desired place to work. About You We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Tertiary qualification in any discipline within Life sciences or Pharmacy. Post-graduate qualification (e.g. Masters) in an industry relevant field. Knowledge, Skills Experience: Must have significant experience in Drug safety or Pharmacovigilance activities. Proven ability to analyze scientific data. Medical Writing experience (e.g. PSURs, Safety variations, RMPs, Clinical and Non-Clinical components of product dossiers). Experience in Compliance tracking (e.g. PSMF, safety databases) and Pharmacovigilance Audits. Open and adaptable to challenging environments. Ability to work with different Global culture and different time zones. Excellent attention to detail and innovative solution finding ability. Excellent communication skills. Ability to communicate clearly and concisely and use strong writing and verbal skills to communicate facts, figures, and ideas to others. A positive and can-do approach , biased towards finding solutions and embracing change. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment.
