Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Associate Director, Aggregate Report Quality (ARQ) is responsible for leading and performing activities which support aggregate safety reports, audits/inspections, IT output quality management and aggregate submission activities. The Associate Director stays current on existing and emerging regulations and guidance pertaining to pharmacovigilance, monitors Regulatory/Health Authority Assessment Reports for trends and contributes to the aggregate report schedule. On a continual basis actively works to promote operational excellence by leading the monitoring, developing, and improving of processes related to aggregate report operational business processes.
- Investigate and collaborate with IT to improve outputs, as well as act as a subject matter expert in technological tools to facilitate transfer of aggregate reports and listings to PV Reports.
- Collaborate with their counterparts in the Regulatory organization to ensure the quality of each aggregate submission.
- Serve as subject matter expert for global Health Authority compliance by interpreting and applying PV regulations and guidelines of individual adverse experience (AE) and aggregate reporting globally.
- Collaborate with and maintain effective working relationships with the Global Safety community and external customers to ensure compliant adverse experience and aggregate safety reporting while also meeting quality standards.
- Liaise with Business Partners to ensure compliance with aggregate data exchange.
- Liaise with country PV to ensure standardization and optimization of aggregate safety reports.
- Possess the ability to address questions and provide leadership to the ARQ team, as well as escalation to management, if necessary.
- Prepares and responds to Regulatory Agency Inspections, as well as internal and external audits.
- Monitor Regulatory/Health Authority Aggregate Assessment Reports and requests for information and ensures implementation of appropriate actions to address compliance and quality issues.
- Process incoming communications from internal and external sources related to regulatory guidance for aggregate safety reports and initiates appropriate course of action and/or response.
- Ensure timely updates of applicable SOPs.
Required Experience and Skills:
- Candidate is required to have at least 5 years of safety/pharmacovigilance experience or related areas such as Clinical Risk Management, Clinical or Regulatory.
- Strong working knowledge of PV regulations (spontaneous and clinical) and safety systems for collection of adverse event information and global aggregate reporting.
- In-depth understanding of business processes and objectives of customers.
- Proven ability to collaborate across divisions to drive results.
- Function at a high level of autonomy.
- Excellent written and verbal communication skills including presentations to senior management.
- Technically proficient in Argus Safety and reporting functionality.
Preferred Experience and Skills:
- Ability to identify compliance risks and develop solutions to minimize risk and improve quality management.
- Ability to lead cross-functional working teams to achieve PV objectives.
- Ability to quickly adapt to changes in business priorities and effectively manage competing priorities.
- Technically proficient in Microsoft Excel and Spotfire.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org. Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC GINA Supplement