Product Manager, PV Reporting and Surveillance

Description

The Position

Our IT team partners with the business to deliver innovative solutions that help everyone be more productive. The Research & Development Division IT team is seeking a Product Manager – PV Reporting and Surveillance , reporting to the Product Line Lead for Clinical Safety. You will lead the strategy, processes, and systems for pharmacovigilance (PV), ensuring regulatory compliance and high quality standards.

The ideal candidate combines digital technology, business strategy, user experience, and agile delivery skills with an entrepreneurial drive, and can guide peers and influence decision-makers to turn stakeholder needs into real solutions.

What will you do?

Partner with cross-functional teams to develop and implement PV strategies that ensure patient safety, quality, and compliance.

Own the product strategy, roadmap, and prioritized backlog of changes.

Manage PV systems, including adverse event reporting and signal detection tools.

Stay current on global PV regulations (e.g., ICH guidelines) and ensure processes and systems comply.

Maintain quality standards and controls that ensure data accuracy and integrity.

Work with clinical, regulatory, and safety teams to integrate PV into the overall product development plan.

Partner with business technology teams to deliver new PVQC systems and changes on time.

Manage stakeholders effectively.

Requirements

• Senior-level experience in enterprise, business, information, systems, application, or solution architecture.
• 5+ years of experience in a health authority–regulated environment.
• Knowledge of pharmaceutical R&D and Global Safety Case Intake, Processing, Management, and Reporting.
• Proven ability to communicate with executives, business leaders, and global IT peers while balancing conflicting priorities and tactical and strategic needs.
• Experience setting product strategy and execution plans across matrixed IT and business organizations.
• Strong vendor relationships that influence platform roadmaps.
• Agile development, testing, and implementation experience in hosted and cloud environments, including architecture, information, and UI design.
• Ability to analyze business needs and coordinate vendors and stakeholders to deliver timely, quality support.
• Strong project management, leadership, and pragmatic problem-solving skills.
• Self-motivated and able to work with little direction in a complex, fast-changing environment.
• Understanding of PV, medical affairs, clinical operations, and product quality complaint processes and systems.
• Working knowledge of Veeva Vault Safety, Vault Safety Docs, Workbench, and Signal.
• Knowledge of IT regulatory requirements such as 21 CFR Part 11, Annex 11, GLP/GCP, and Computer Systems Validation.
• Familiarity with risk-based monitoring and other PV industry applications.

Benefits

• Exciting work in a great team, global projects, international environment.
• Opportunity to learn and grow professionally within the company globally.
• Hybrid working model, flexible role pattern (e.g., even 80% full-time is possible in justified cases).
• Pension and health insurance contributions.
• Internal reward system plus referral programme.
• 5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks of parental contribution.
• Cafeteria for tax free benefits according to your choice (meal vouchers, sport, culture, health, travel, etc.), Multisport Card.
• Vodafone, Raiffeisen Bank and Foodora discount programmes.
• Up-to-date laptop and iPhone.
• Parking in the garage, showers, refreshments, massage chairs, library, music corner.
• Competitive salary, incentive pay, and many more.
• Ready to take up the challenge? Apply now!
• Know anybody who might be interested? Refer this job!
• Additional location(s) Compensation Information:
• Required Skills:
• Digital Transformation Initiatives, Implementation Management, Incident Management, ITIL Service Delivery, IT Infrastructure Management, Manufacturing Compliance, Objectives and Key Results (OKRs), Patient Safety, Pharmacovigilance, Process Leadership, Regulatory Compliance, Scientific Software Development, Software Development Life Cycle (SDLC), Stakeholder Management, Technical Leadership
• Preferred Skills:
• Current Employees apply HERE
• Current Contingent Workers apply 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:
• Domestic
• VISA Sponsorship:
• No
• Travel Requirements:
• No Travel Required
• Flexible Work Arrangements:
• Hybrid
• Shift:
• Not Indicated
• Valid Driving License:
• No
• Hazardous Material(s):
• n/a
• Job Posting End Date:
• 11/30/2026
• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.