Specialist Drug Safety

About the Role

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:

• Draft/Review of Periodic Safety Update Reports and Periodic Adverse Drug Experience Reports from a medical standpoint.
• To prepare Signal reports (including DSR, DEP, SAR as applicable) and managing the compliance and quality of signal detection.
• Medical writing to support product safety reviews and clinical evaluations.
• Support if required to draft/review ad hoc safety reports like RMP, CES, HA response in stipulated time frame.
• Contribute towards continued improvement of safety systems and processes.
• Oversight of safety related variations and maintenance of product information.
• Keep abreast of changing PV requirements across Europe and Rest of World.
• Represent the company during Scientific meetings and Audits and Inspections.
• Compliance with GPvP requirements, demonstrated through audits and inspections.
• Support to the business and provision of documentation within agreed timeframes.
• Successful relationships with all external partners.
• Address internal and external inspection findings.
• Ensure all documentation is structured and maintained as required
• Ensure PV systems are in line with industry standards.
• Interaction with Regulators, patients and prescribers from a safety perspective if required.
• 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 in a pharmaceutical company.
• 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.