Senior Director Aggregate Safety Assessment
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care 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 care-givers, 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.
Amongst the main responsibilities for this role are the following:
- Lead and oversee the periodic aggregate safety reporting activities in Global Pharmacovigilance (GPV) to enhance quality of Astellas pharmacovigilance activities and to ensure excellence in periodic aggregate safety reports mandated by worldwide regulatory authorities
- Establish the best practice of periodic aggregate safety reporting activities as well as ad-hoc reporting to ensure the safety of Astellas' products
- Ensure that GPV staff is fully and appropriately informed of, and trained on, global regulatory requirements and guidelines for periodic reporting
- Establish and maintain closely alliances with relevant functions --both internal (GPV) and external (RA, GMA, Clinical Development) partners -- to ensure high-quality periodic reporting activities
- Strictly comply with all relevant authorities / regulations
- Leads, executes and oversees the worldwide ASA activities: both in-house and outsourced ASA activities.
Essential Knowledge & Experience:
- A postgraduate Science or Medical degree ( PhD, MS, Pharm.D, MD). Additional degree in public health concentration is desirable (e.g. MPH, Epidemiology, etc.).
- Extensive experience in the health science-related industry with direct exposure to clinical, regulatory or pharmacovigilance functions including;
- Significant pharmacovigilance experience (advanced pharmacovigilance functions from development and post-authorization)
- Management or team experience, managing academic level professionals (e.g. physicians, scientists).
- Direct management experience.
- Significant and demonstrable working knowledge of global pharmacovigilance regulations and guidelines, including US, ICH and EU regulations.
- Currently this position has the flexibility to work from home and in the office.
- Full time.
- The position can be based in the US, Netherlands, UK or in Japan.
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.