Job Description
The Information Technology team at our Company's R&D division (our Research & Development Division) is looking for Product Manager – PV Signaling, Analytics & Reporting. Reporting into Product Line Lead Patient Safety, Quality & Compliance, this position will be responsible for managing the development and implementation of pharmacovigilance strategies, processes, and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high-quality standards.
Product managers must possess a broad base of skills and knowledge spanning digital technology, strategy and business planning, user experience design, engineering, and agile/lean development practices. They must possess an entrepreneurial drive to develop new product features while managing stakeholder needs and timeframes to broker complex relationships that evolve into real solutions. The ultimate success of a product owner hinges on their ability to guide their peers while influencing decision-makers.
The following are the key responsibilities of a PV Signaling, Analytics & Reporting Product Manager.
Develop and implement PV strategies: Work with cross-functional teams to develop and implement pharmacovigilance strategies that meet regulatory requirements and ensure patient safety, quality and compliance.
Oversee PV processes: Responsible for overseeing all PV processes, including adverse event reporting, signal detection, and risk management activities.
Manage PV systems: Responsible for managing PV systems, including software systems used for adverse event reporting and signal detection.
Maintain PV knowledge: Maintain up-to-date knowledge of global PV regulations and guidelines and ensure that the company’s PV processes and systems comply with these regulations.
Ensure compliance with regulations: Responsible for ensuring that the company's PV processes and systems are in compliance with regulatory requirements, such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
Maintain quality standards: Responsible for maintaining high-quality standards for PV processes and systems, and for implementing quality control measures to ensure data accuracy and integrity.
Collaborate with other departments: Collaborate with departments such as clinical, regulatory, and safety to ensure that PV processes are integrated into the overall product development plan.
Communicate PV information to internal and external stakeholders, such as regulatory authorities, health care professionals, and patients.
Lead PV projects: Partnering with the business technology partner, managing the implementation new PVQC systems and changes, and ensuring that project timelines are met.
Required Experience and Skills:
10+ years prior experience in Enterprise, Business, Information, Systems & Application or Solution Architecture
5+ years prior experience in a health authority regulated environment
Demonstrated ability to effectively partner and communicate with a variety of audiences and stakeholders including executive management, business leaders, IT peers, and colleagues worldwide to navigate across conflicting priorities and balance critical tactical and strategic needs
Strong problem-solving skills with a pragmatic approach to addressing challenges
Self-directed, self-motivated, driven professional who with little direction can fill in the gaps as to what is needed, and drive expected results
Has the ability to be self-motivated to understand current Patient Safety business needs and current architecture, platforms and systems.
Experience establishing strategy and execution plans for products to enable best-in-class IT capabilities.
Demonstrated partnership working with matrixed IT and client organizations to drive highest value business outcomes aligned to business and future state technology strategies.
History of developing strong relationships with key vendors to influence vendor’s strategic roadmaps and provide transparency around platform roadmaps.
Knowledge and experience with Agile Application development, testing and implementation in external hosting and cloud environments.
Ability for envisioning architectural scheme, information structure and features, functionality, and user-interface designs; leverages current best practices in cloud-based design and development.
Experience identifying and analyzing business needs and coordinating between product vendors and other stakeholder groups to deliver prompt, efficient and, quality support.
Demonstrated ability to succeed in a complex and dynamic work environment
Strong project management, communication, and leadership skills, as well as a thorough understanding of regulatory requirements and quality standards.
Knowledge of Research and Development within pharmaceuticals life science industry as well as experience with Global Safety Case Intake, Processing, Management and Reporting.
Preferred Capabilities:
Understanding of pharmacovigilance, medical affairs, clinical operations and product quality complaints processes and systems
Working Knowledge of some not all of Oracle Argus, Veeva, RxLogix suite of technology products.
Understanding of regulatory requirements that drive IT delivery, including 21-CFR-Part-11, Annex 11, Good Laboratory and Clinical practices, Computer Systems Validation, and other global regulatory requirements that impact IT systems in the R&D and manufacturing spaces
Familiarity with risk-based monitoring and other industry applications used for Pharmacovigilance.
Minimum Education Requirements:
Education:
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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US and Puerto Rico Residents Only:
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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:
$135,500.00 - $213,400.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
na
Required Skills:
Cross-Functional Teamwork, Management Reporting, Management System Development, People Management, Process Engineering, Product Management, Project Management, Requirements Management, Stakeholder Relationship Management, Strategic
Preferred Skills:
Agile Application Development, Business Architecture, Business Strategies, Compliance Monitoring, Computer Science, ICH Guidelines, Information Technology Strategies, ISO 9000, IT Project Lifecycle, IT Service Delivery, Life Science, Medical Affairs, Operating Systems (OS), Pharmaceutical Sciences, Pharmacovigilance, Plan of Action and Milestones (POA&M), Policy Compliance, Process Safety, Project Resource Management, Quality Management, Serious Adverse Event Reporting, Solution Architecture, Stakeholder Engagement, Supplier Management, User Interface Architecture
