ociate Director Of PV Operations

Job DescriptionSummary

As the Associate Director of PVOperations you will develop / oversee of PV processes anddeliverables performed internally contracted independentconsultants and or vendors.

This individual will support the PVinfrastructure with PV operational activities such as managementand support of the relationship with safety vendor(s) to ensureeffectiveness quality and compliance of outsourced activities andsupport departmental budget adherence and other budget relatedKPIs).

Our Pharmaceutical Diagnostics (PDx)business is the number one global supplier of contrast media andmolecular imaging agents used to enhance medical imaging exams.

Used throughout all major disease area diagnostic and treatmentpathways PDx products support three patients every second aroundthe world.

JobDescription

EssentialResponsibilities

• Improve / standardizethe setup of new safety projects vendor management (working withinternal and external colleagues including Quality Assurance andSourcing as needed)
• Manage the process foridentifying evaluating selecting and managing outsourcing vendorsinvolved in safety activities (including regular auditing / requalification and training)
• Responsible forsetting up a collaborative working relationship with suppliers andvendors to ensure regulatory requirementcompliance.
• Maintain oversight of adherence tocontractual agreements.
• Develop / oversee of PVprocesses and deliverables performed internally contractedindependent consultants and or vendors to ensurecompliance / alignment with regulatory requirements and internalpolicies / procedures
• PV Budget activities andmanagement with a strong collaboration with colleagues across theorganization (PV Medical Affairs andFinance)
• Assist in monitoring industry bestpractices and changes in global safety regulations and guidelinesfor marketed and investigational products and recommend changes andupgrades to existing departmental policies SOPs andsystems
• Perform a variety of activities withinthe safety organization including but not limited to monitor andmaintain compliance provide technical expertise and working crossfunctionally with team members and externally with partners andCROs
• PV Audit and inspection participation CAPAmanagement and collaboration with PV Compliance team. Helps tocoordinate the audit process of business partners CROs andvendors
• Awareness of best practices across PVincluding manage process improvements and commitment to Leanmethodologies and activities

Qualifications / Requirements

• Bachelors degree required Masterspreferred
• Minimum of 6years of pharmaceutical / biotechnology industry experience includingat least 2 years PV operations budgetmanagement
• Knowledge of US / EU / AP / LA regulationsand ICH guidelines
• Exposure to workingrelationship with FDA and otherregulatory

authorities

• Experienceworking with third party vendors
• Understandingof pharmacovigilance related informationsystems
• Proficiency working in Windowsbasedwork processing and experience with medical / scientific / regulatorydatabases / resources.
• Must be permitted to workin USA with ability to travel domestically and internationally (Upto 10%).

DesiredCharacteristics

• Global experiencepreferred
• High integrity sense of urgencyability to recognize time sensitivity willingness to work in amatrix environment and assume the role of player / coach asnecessary
• Excellent written and verbalcommunication skills exceptional listening skills strongpresentation skills Excellent analytical negotiating andinfluencing skills
• Budget tracking experienceas well as demonstrated vendor oversight

We expect all employees to live andbreathe our behaviors : to act with humility and build trust; leadwith transparency; deliver with focus and drive ownership alwayswith unyielding integrity.

Our total rewards are designed to unlock your ambition bygiving you the boost and flexibility you need to turn your ideasinto worldchanging realities.

Our salary and benefits areeverything youd expect from an organization with global strengthand scale and youll be surrounded by career opportunities in aculture that fosters care collaboration and support.

LIKC1

For U.S. based positions only the pay range for thisposition is $126480.00$189720.00 Annual. It is not typical for anindividual to be hired at or near the top of the pay range andcompensation decisions are dependent on the facts and circumstancesof each case.

The specific compensation offered to a candidate maybe influenced by a variety of factors including skillsqualifications experience and location.

In addition this positionmay also be eligible to earn performance based incentivecompensation which may include cash bonus(es) and / or long termincentives (LTI).

GE HealthCare offers a competitive benefitspackage including not but limited to medical dental vision paidtime off a 401(k) plan with employee and company contributionopportunities life disability and accident insurance and tuitionreimbursement.

AdditionalInformation

GE HealthCare offers agreat work environment professional development challenging careersand competitive compensation. GE HealthCare is anEqual OpportunityEmployer.

Employment decisions are made without regard to race colorreligion national or ethnic origin sex sexual orientation genderidentity or expression age disability protected veteran status orother characteristics protected by law.

GE HealthCare will onlyemploy those who are legally authorized to work in the UnitedStates for this opening. Any offer of employment is conditionedupon the successful completion of a drug screen (asapplicable).

While GE HealthCare does notcurrently require U.S. employees to be vaccinated against COVID19some GE HealthCare customers have vaccination mandates that mayapply to certain GE HealthCareemployees.

Lifelancer( ) is a talenthiring platform in Life Sciences Pharmaand IT. The platform connects talent with opportunities in pharmabiotech health sciences healthtech data science and ITdomains.

Please use the below Lifelancer linkfor job application and quickerresponse.

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