Senior Expert – Regional Pharmacovigilance
291098
Bangalore, Karnataka, India
Full-time (Part-time possible)
At Merck, we are driven by curiosity and a commitment to advancing human progress through science and technology. Our diverse teams across the globe work in Healthcare, Life Science, and Electronics to discover solutions that improve and enrich lives. We aim to create, improve, and prolong lives, particularly in therapeutic areas such as Oncology, Neurology, and Fertility.
As a Senior Expert – Regional Pharmacovigilance (PV), you will be part of the Process Management and Process Excellence Team within RQS Operations (Regulatory, Quality, and Safety). This role focuses on simplifying and improving the RQS process landscape using a risk-based approach and AI-driven innovation.
You will work closely with the Global Patient Safety (GPS) team and other stakeholders to support and maintain the local PV systems, manage Risk Management Plans, and ensure inspection readiness across multiple regions.
Support PV activities in collaboration with global and local stakeholders.
Maintain local Pharmacovigilance Systems and document in PV System Master Files.
Author, coordinate, and review local Risk Management Plans (RMPs).
Drive process improvement, automation, and AI-based tool implementation.
Ensure audit and inspection readiness for processes and documentation in scope.
Prioritize tasks and projects using a risk-based approach.
Apply global and local pharmaceutical regulations in everyday processes.
Master’s degree in Pharmacy, Life Sciences, or equivalent.
Preferred: Licensed Pharmacist or Ph.D. in Life Sciences.
Minimum 8 years in the pharmaceutical or CRO industry, with at least 3 of the following PV areas:
PV system setup and maintenance (global/local/regional)
Authoring/review of PV System Master Files
Acting as Business Process Owner
Collaboration between local and global PV teams
Implementation of additional Risk Minimization Measures (RMMs)
Handling audits and inspections
Preferred: Experience in a global industry setting
Strong understanding of post-marketing pharmacovigilance, safety risk management, and regulatory frameworks.
Ability to manage competing priorities across global time zones.
Proactive, solution-oriented and customer-focused mindset.
Excellent verbal and written English communication skills; additional languages are a plus.
Experience with AI tools and project management is an advantage.
Strong interpersonal skills with the ability to work in multicultural and cross-functional teams.
Competitive compensation and financial benefits to support long-term stability.
Comprehensive health checkups and medical insurance for physical and mental wellness.
Benefits that support all life stages, including fertility assistance.
Leave policies tailored to allow time for recharging and managing life events.
Access to flexible working, gym memberships, shopping discounts, and more.
Application:
Submit your application through our official career site.
Screening:
Your qualifications will be reviewed by our recruitment team.
Assessment:
Interview rounds via phone, video, or in-person.
Mutual Agreement:
If you’re a fit, we’ll move forward with an offer.
Onboarding:
Begin your journey with us through a structured onboarding program.
Be cautious of unauthorized job offers. Always apply via the official Merck website and stay informed about fraudulent hiring practices here.
Merck values diversity and promotes an inclusive workplace culture. We are committed to creating equal opportunities for all employees to develop and grow.
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