Associate Director, Pharmacovigilance Quality Assurance Auditor

Job Description

The position

The Associate Director, Pharmacovigilance (PV) Quality Assurance Auditor, is responsible for ensuring quality and compliance with local and international regulatory requirements by conducting audits of Organon Processes, Affiliates, Vendors, Business Partners, and Investigator sites. The Associate Director is responsible for accepting audit assignments, performing audit pre-work, conducting audits and ensuring post audit activities are completed within defined timeframes.  This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance strategy and the resolution and prevention of compliance risks.

Responsibilities:

• Schedule and conduct assigned PV audits in accordance with the global audit plan ensuring compliance with local and international guidelines and regulations.

• Prepare audit reports and manage follow-up activities within established timelines.

• Maintain broad-based expertise in Organon Policies, Procedures and Guidelines, local and global regulatory requirements, etc., pertinent to GVP. Maintain awareness of evolving industry and regulatory trends/regulations.

• Obtain and maintain cutting-edge knowledge, and application, for various Quality auditing topics.

• Generate and present comprehensive presentations/summary of audit issues for effective communication to all levels, as needed.

• Leads initiatives / drive results in various projects, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet company and regulatory expectations.

• Supports the implementation and maintenance of the PV risk-based strategy, including assistance in the development of the annual audit plan and maintenance of the audit tool.

• Reviews and provides input into the quality sections of the Pharmacovigilance System Master File (PSMF).

• Supports regulatory inspections and external audits, when required.

• Train and mentor junior team members.

  

Required Education, Experience, and Skills

• A minimum of a Bachelor’s degree in a relevant scientific field (Pharmacy, Life Sciences, etc.).

• Fluency in written and spoken English; additional language skills a plus.

• Minimum of ten (10) years of experience in the pharmaceutical industry or regulatory agency related to Quality Systems and Quality Assurance (e.g., clinical trial quality, pharmacovigilance, regulatory).

• Minimum of one (1) year of experience in PV auditing with EU/FDA /global regulatory requirements.

• Strong knowledge of EMA, FDA and ICH guidelines in GVP and proficiency in interpreting and applying regulatory requirements and guidelines.

• Attention to detail and ability to work independently in a virtual environment.

• Proficiency in Microsoft applications (Word, Excel, PowerPoint, Outlook).

• Excellent/accomplished communication, negotiation, facilitation, influencing, and strategic thinking skills at all levels of organization Availability to travel up to 20% of time.

• Collaboration and Partnering:  Demonstrates ability to work in partnership with others within the Company and external partners to accomplish quality goals; possesses advanced leadership skills.

• Communication Skills:  Strong verbal skills and experienced effective writing skills.

• Project Management:  Demonstrates ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations. 

• Decision Making:  Demonstrates skills to utilize knowledge, networks, and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.

• Business Operations/Knowledge of Field: Demonstrates knowledge of regulations. Regulatory and business trends and applies this knowledge to optimize daily activities and ensure the functional areas within Research and Development are compliant with regulations and appropriate procedures. 

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. 

Search Firm Representatives Please Read Carefully 
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1