Pharmacovigilance Scientist (Senior Manager)

Pharmacovigilance Scientist (Senior Manager)

Markham, ON

At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.

What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.

Making a positive impact on patients' lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.

About Us:

We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.

In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.

We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.

From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.

Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.

Description

Working in collaboration with the Global Safety Officer (GSO), the PV Scientist has primary responsibility for the execution as safety signal detection and case series data analyses for his/her assigned Astellas products (either in development or marketed products). Additionally, the PV Scientist may also support aggregate safety data preparation or presentation at internal / external safety review meetings and may collaborate with medical writing to ensure optimal presentation in written safety assessments or communications.

Essential Job Duties:

Acting as key member of the PV Product Responsible team for his/her assigned products, and in close collaboration with the GSO, the PVS will:

Assist the GSO in the coordination of medical-scientific monitoring and assessment of the safety profile of one or more Astellas products.

Assist the GSO with the preparation of meeting materials/presentations for PV product meetings such as but not limited to:

Product Responsible Teams

Core Clinical Development and Core Medical Teams

Global Development Safety Management Teams

Joint Safety Management Teams

Core Teams (Extended)

And Global Medical Affairs Core Medical Team

The PVS may also, as requested, attend these meetings with the GSO.

The GSO owns the strategic priorities and drives implementation, while the PVS supports and contributes as necessary applying knowledge of Therapeutic Area, regulatory science, and signal surveillance to manage characterization of the compound/product safety & benefit-risk profile. These activities will include, but not be limited to:

Supporting the GSO in the development of the initial safety surveillance development strategy and leading subsequent updates to this strategy;

Performing the first level safety signal detection and signal evaluation activities (e.g., safety database and literature review, health authority queries) for Astellas products, and finalizing these assessments in conjunction with the GSO

Support the GSO for inspection /audit readiness activities and CAPA commitments.

In partnership with the GSO, provide guidance and support to Medical Writing vendors in developing key deliverables by actively participating in working sessions to create timely deliverables, share perspectives, and suggest improvements such as:

Working closely with the GSO and vendor, contribute to risk management activities of assigned products, including preparation of the Risk Management Plans (RMP) and execution of risk management strategies in collaboration with internal and external stakeholders.

Collaborate with the vendor and contribute in the preparation of the relevant signal and risk evaluation sections of the PSUR, DSUR and PADERs.

Support Medical Writing in the preparation of periodic and ad hoc (e.g. Health authority requests) safety reports for assigned products in terms of contributing to sections and aiding the GSO in drafting/authoring these sections.

Draft revisions of RSI section and expected events list for the IB in conjunction with risk evaluation during DSUR preparation and/or signal evaluations.

Responsible for the accuracy, quality, and timeliness of all assigned responsibilities and tasks

Assist with data requests, document preparation and/or review of data.

If requested, support the Drug Safety Assistant with activities such as meeting scheduling, meeting minutes, and tracking of adherence to deliverables.

Required Qualifications

A postgraduate Science or Medical degree or Bachelor's degree in a healthcare field (PhD, MS, Pharm.D, MD, RN).

At least 6 years of experience in the health science-related industry with direct exposure to clinical, regulatory or pharmacovigilance functions, including;

2 or more years pharmacovigilance experience (advanced pharmacovigilance functions from development and post-authorization)

Understanding of ICH/FDA regulations and guidelines affecting drug safety issues.

Thorough understanding of safety signaling activities.

Competence in safety surveillance analysis and presentation, orally and in writing.

Must be proficient with technology (Windows, Word, Excel, Outlook, PowerPoint). Proficiency in MS Teams and SharePoint desired.

Proficiency in English language, both oral and written, to support working in global environment.

Ability to communicate within the organization and present ideas both orally and in writing.

Skills in managing/overseeing people.

Comfortable in a fast-paced, high-pressure company environment and able to adapt to changing priorities.

Ability to deliver under pressure.

Demonstrated ability to recognize, anticipate and communicate issues proactively.

Ability to drive decision-making and influence stakeholders in a matrix environment.

Ability to deliver timely and high-quality documents.

Preferred:

Prior experience conducting signal detection and safety analyses as part of safety surveillance activities

Direct experience contributing to periodic safety reports

Additional Information

Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.

Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation.

No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted.

Category Medical Safety Science

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans