Pharmacovigilance Manager

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where the patient’s need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work with patients, doctors, and healthcare professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team, or division.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their caregivers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access, and ultimately standards of care.

About the role:

Astellas is searching for a committed and passionate Pharmacovigilance (PV) Manager to join our team! As a PV Manager, you will be responsible for maintaining excellence in PV activities across the affiliate. Reporting to the Director, this role will play a critical part in the successful implementation and execution of the Global Strategic Plan.

Your key responsibilities will include:

• Acting as local Drug Safety Officer (DSO) and local qualify person for PV
• Developing and implementing procedures to ensure compliance with both local and regional PV regulations and Astellas global and regional policies and procedures.
• Close collaboration with relevant stakeholders on matters relating to operational management and compliance are impacting PV
• Management of product safety information (adverse event) from all sources such as day-to-day case processing, reconciliation
• Maintenance of PV system and oversight including provide input to PSMF, inspection/audit readiness, CAPA management, vendor oversight, oversight and monitoring of local studies and projects that impacts PV
• Coordinate development and execution of PV product Safety awareness training to affiliate staffs and third-party personnel providing PV-related activities
• Line management of junior colleagues (if applicable)

Essential Knowledge & Experience:

• Experience within PV and/or combined PV/RA/QA; to include direct contact and engagement with national competent authorities
• Good understanding of establishing and maintaining (GxP) Quality Management Systems
• Awareness of local industry code(s) of practice and local and/or regional PV regulations and guidelines.
• Experience in supporting a PV system in at least one single country; low complexity, low case volume.
• Awareness and experience with some aspects of a PV quality management system
• Proficiency in local language and business English language (written, verbal, presentation, facilitation)

Preferred Knowledge & Experience:

• Project Management experience (scope, interdependencies, budgeting, critical path analysis, reporting)
• Fluency in an additional language is preferred
• Flexible, customer-focused, and determined attitude
• Solution-oriented and effective problem-solving skills

Education/Qualifications:

• Minimum BA/BS (Pharmacy, Medical, or Biomedical/Life Sciences preferred) preferably with an advanced professional degree

Additional information:

• Attractive salary plus super
• Medium-sized pharmaceutical company with a strong pipeline
• Inspiring work environment
• Employee Referral Bonus Program
• Gain extensive experience in the Pharmaceutical Industry and develop your professional portfolio

If you are ready to make the next step in your career - APPLY NOW

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.