CAREER PORTAL

Sr. Manager, Global Pharmacovigilance Auditing / Quality Assurance

JOB ID:  CAMB000026
Sr. Manager, Global Pharmacovigilance / PV Auditing
Cambridge, MA (Hybrid, 2 days onsite)
Manager will consider remote for the right candidate
Contract (leave coverage, 5 months with possible extension)
Pay Rate: $100 - $110 (depending on experience)

***A CDA will be required for an interview

***Preference is 10 years’ experience (minimum 5 years) with PV Auditing is a must.  

***The successful candidate will have post-market experience along with PV system auditing (scoping out, planning and managing aspects of an audit).

Please note:  This is not a PV operational / compliance position.  It's a traditional PV QA role focused on auditing, deviation management and oversight of the PV quality system.  

Experienced needed for this role:

• Strong GVP experience (Good Pharmacovigilance Practices)
• GVP auditing, risk criteria and experience evaluating suppliers in a GVP regulated environment
• Experience supporting quality issues
• Experience with medical affairs and regulatory requirements
• Strong cross-functional collaboration experience, flexibility, proactive communication and ability to work independently

Summary: This role is a member of a QA team providing quality oversight of global post-marketing pharmacovigilance system, including clinical safety, full application of EMA Good Pharmacovigilance Practices (GVP) Modules, and implementation of other worldwide PV regulations. This includes support for the development and execution of the GVP audit program as well as contributing to inspection activities.

Other Experience & Requirements for this role:

• Audit skills and experience of conducting GVP audits is preferred.
• Understanding of and working experience with international GVP regulations, FDA PV requirements, Health Authority guidance and ICH.
• Experience supporting Health Agency inspections.
• Self-motivated with the ability to demonstrate initiative and internal drive for continuous improvement.
• Strong interpersonal, verbal, and written communication skills.
• Builds positive and productive working relationships.
• Diplomatic in addressing sensitive issues confidentially and professionally.
• Works professionally with confidential information.
• Ability to analyze complex situations / issues.

Responsibilities:

• Senior Manager, PV QA supports all the GVP QA’s responsibilities as listed below.
• Different members of the team will have particular focus areas.

Senior Manager will lead specific activities:

• Serve as a strong partner with Expertise Areas (EAs) in the enhancement of the global pharmacovigilance system, including ensuring compliance with GVP regulations (this includes review of procedural documents).
• Partner and support EAs in ensuring conduct of non-interventional, observational, and post-marketing surveillance (PMS) meet regulatory requirements and expectations considering Good Pharmacoepidemiology Practice (GPP) and Good Post-marketing Study Practice (GPSP)
• Support cross GxP QA activities requiring PV and PMS expertise.
• Execute on global core auditing processes for licensing partners, external vendors, internal audits, affiliates, and other applicable service providers in a post-marketing environment.
• Determine, evaluate and investigate Quality Events.
• Determine adequacy of root cause analyses and CAPAs.

Support the Global Strategic Audit Program  - contribute to risk-based audit strategy and maintain and enhance PV audit universe, risk tools and develop PV audit schedule.

• Provide QA Audit, CAPA and Supplier data for the PV System Master File (PSMF).
• Develop and maintain efficient processes to ensure comprehensive and accurate data.
• Develop and maintain processes and tools to support quality audit execution and outcomes.
• Support PV / post-marketing surveillance inspection readiness and inspection management activities.
• Provide Quality oversight of PV, PMS and PV-related vendors
• Develop and report GVP QA metrics and dashboards to support quality oversight.
• Develop and maintain GVP QA Training Plan; conduct PV and PMS training sessions for QA and EAs.
• Lead or contribute to Quality or PV and PMS initiatives.
•  Identify and propose process improvement opportunities and solutions.

Estimated Min Rate: $100.00
Estimated Max Rate: $110.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.