Job Description SummaryAs the Associate Director of PV Operations, you will develop/oversee execution of PV processes and deliverables performed internally, contracted independent consultants, and or vendors. This individual will support the PV infrastructure with PV operational activities such as management and support of the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of outsourced activities and support departmental budget adherence and other budget related KPIs).Our Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.Job DescriptionEssential Responsibilities
Improve/standardize the set-up of new safety projects, vendor management (working with internal and external colleagues including Quality Assurance and Sourcing, as needed)
Manage the process for identifying, evaluating, selecting and managing outsourcing vendors involved in safety activities (including regular auditing/ requalification and training)
Responsible for setting up a collaborative working relationship with suppliers and vendors to ensure regulatory requirement compliance.
Maintain oversight of adherence to contractual agreements.
Develop/oversee execution of PV processes and deliverables performed internally, contracted independent consultants, and or vendors to ensure compliance/alignment with regulatory requirements and internal policies/procedures
PV Budget activities and management with a strong collaboration with colleagues across the organization (PV, Medical Affairs and Finance)
Assist in monitoring industry best practices, and changes in global safety regulations and guidelines for marketed and investigational products, and recommend changes and upgrades to existing departmental policies, SOPs and systems
Perform a variety of activities within the safety organization, including but not limited to monitor and maintain compliance, provide technical expertise, and working cross functionally with team members and externally with partners and CROs
PV Audit and inspection participation, CAPA management and collaboration with PV Compliance team. Helps to coordinate the audit process of business partners, CROs, and vendors
Awareness of best practices across PV including, manage process improvements and commitment to Lean methodologies and activities
Qualifications/Requirements
Bachelor’s degree required, Masters preferred
Minimum of 6 years of pharmaceutical/biotechnology industry experience including at least 2 years PV operations, budget management
Knowledge of US/EU/AP/LA regulations and ICH guidelines
Exposure to working relationship with FDA and other regulatoryauthorities
Experience working with third party vendors
Understanding of pharmacovigilance related information systems
Proficiency working in Windows-based work processing and experience with medical/scientific/regulatory databases/resources.
Must be permitted to work in USA with ability to travel domestically and internationally (Up to 10%).
Desired Characteristics
Global experience preferred
High integrity, sense of urgency, ability to recognize time sensitivity, willingness to work in a matrix environment and assume the role of “player/coach” as necessary
Excellent written and verbal communication skills, exceptional listening skills, strong presentation skills, Excellent analytical, negotiating and influencing skills
Budget tracking experience, as well as demonstrated vendor oversight
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.#LI-KC1For U.S. based positions only, the pay range for this position is $126,480.00-$189,720.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional InformationGE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf) . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.Relocation Assistance Provided: No
