Director Global Patient Safety

Director Global Patient Safety





What you will do

Let’s do this. Let’s change the world. This Pharmacovigilance Lead for the Amgen India Center will oversee all pharmacovigilance activities and staff at the India site, working closely with the global teams while ensuring compliance with global regulations and company standards. This role requires a strong leader with a deep understanding of patient safety, regulatory requirements, and people leadership/ management, along with experience in innovation and technology.

This staff member will provide site-level leadership to the entire pharmacovigilance team based in India, maintaining operational and strategic oversight and support for day-to-day activities including PV Operations, Signal and Risk management activities, while reporting into the Global Head of Pharmacovigilance Operations.

Provide direction, strategy and leadership for pharmacovigilance activities at the India site

Support and contribute to innovation initiatives across the Safety function

Ensure compliance with global pharmacovigilance regulations, guidelines, and company policies as well as high quality deliverables.

Lead, mentor, and develop a team of pharmacovigilance professionals located in India office.

Work closely with global pharmacovigilance team leads, and other site functional leads to ensure alignment of processes, systems and activities as required.

Work with global team leads to ensure that there is an adequate number of qualified personnel to perform pharmacovigilance activities and responsibilities at the India site.

Continuously assess and review pharmacovigilance processes and systems to identify enhancements for increased efficiency and effectiveness.

Develop and implement training programs as required for pharmacovigilance staff located in India.

Support pharmacovigilance audits and inspections.

Support business continuity at the India site aligned with global responsibilities

Work with key internal stakeholders to enable issues resolution and continuous improvement.

Communicate issues and action plans to management, leveraging appropriate quality management systems to escalate accordingly

Ensures appropriate identification of critical events and escalation per business process

Escalates critical issues and findings to ensure incorporation into Management Review

Leads cross-functional initiatives

Interprets SOPs and regulatory requirements and provides oversight to ensure they are followed

Sets project timelines and priorities for key initiatives and/or team activities

Provides guidance and technical advice to key stakeholders

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Strong people management skills and ability to lead and develop effective teams.

Ability to understand and communicate scientific/clinical information.

Experience with Safety technology and Innovation development

Understanding of regulatory activities and how it affects projects and processes across regions and cross-functionally.

Ability to effectively collaborate with global teams to set organizational direction and champion change and continuous improvement.

Ability to anticipate and mitigate future strategic issues & uncertainties. Analyzes problems and process breakdowns to ensure that improvements are made.

Ability to work across a team.

Good communication skills - both oral and written.

Good negotiation and Influencing skills.

Ability to anticipate and prevent potential issues.

Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.

Cultural awareness and sensitivity to achieve results across both regional, country, and international borders.

Ability to Manage multiple activities and set priorities.

Coach others to analyze information and evaluate alternatives to solve problems when appropriate.

Fosters a culture that encourages and supports high ethical standards, diversity, inclusion and belonging.

Basic Qualifications:

Master’s degree and 12 years directly related experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments.

OR

Bachelor’s degree and 15 years directly related experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments.

AND

6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

Medical degree, Doctorate degree, PharmD, MD, Nurse (BSN, RN, etc.) or equivalent

Minimum of 10 years of experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments.

A minimum of 6 years of functional management experience overseeing PV staff

A thorough understanding of the global PV regulatory environment with working knowledge of EU and US regulations, ICH guidelines, and GCP, a working understanding of drug safety databases, effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective

Leadership skills and the ability to oversee multiple projects simultaneously

Able to successfully manage workload to timelines

Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions

Familiarity with basic project management tools

Ability to negotiate a strategic position after taking feedback from multiple sources

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.



Apply now



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As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.