患者安全专员
Notify me about similar jobsMerck KGaA has closed or removed this posting -- see current similar openings below.
About this opportunity
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your role:
Provides various office and location support activities. Identifies, enhances, and follows specific processes and procedures to maximize the efficiency of the business being supported; ensures the correct functioning of facilities, office, and/or business support services. The role is directly accountable for performing all pharmacovigilance (PV) tasks allocated to the Local Patient Safety organization under the supervision of the Local Patient Safety Officer (LPSO) in a given country/territory. Tasks must be performed in full compliance with all relevant global and local regulatory requirements and company standards. This includes, but is not limited to:
1. Individual Case Safety Report (ICSR) Management
Responsible for the end-to-end management of local safety cases, including adverse event collection, case intake, translation, quality review, follow-up activities, and submission to health authorities and ethics committees, ensuring that all safety reports are processed accurately, completely, and within regulatory timelines.
2. PV Compliance and Operational Oversight
Ensures ongoing compliance of local pharmacovigilance activities through reconciliation, quality monitoring, compliance reporting, and business continuity management, while proactively identifying and mitigating compliance risks in accordance with global and local requirements.
3. Local PV System Maintenance
Supports the establishment, maintenance, and continuous improvement of the local pharmacovigilance system, including maintenance of the Local PV File (LPVF) and related documentation, ensuring sustained inspection readiness and compliance with regulatory obligations.
4. Clinical Study and Patient Program Support
Acts as the pharmacovigilance representative for clinical studies and Patient Data Collection Systems (PDCS), providing safety input to study documentation, supporting adverse event reconciliation, and ensuring compliance with pharmacovigilance requirements throughout study and program execution.
5. Risk Management and Aggregate Safety Reporting
Supports the development and implementation of Risk Management Plans (RMPs), contributes to periodic safety reporting activities, and facilitates the execution of risk minimization measures to support the ongoing benefit-risk evaluation of products throughout their lifecycle.
6. Partner and Vendor Pharmacovigilance Management
Supports the management of Safety Data Exchange Agreements (SDEAs), pharmacovigilance contractual requirements, and vendor oversight activities to ensure that business partners and third parties fulfill their pharmacovigilance responsibilities in a compliant and effective manner.
7. Regulatory Intelligence and Health Authority Engagement
Monitors local pharmacovigilance regulations, assesses the impact of regulatory changes on business operations, and supports safety-related interactions with health authorities, ensuring timely communication and appropriate responses to regulatory requests and inquiries.
8. Training, Audits, Inspections, and Continuous Improvement
Contributes to pharmacovigilance training, audits, inspections, and CAPA activities, supporting organizational learning, compliance enhancement, and continuous improvement to maintain a robust and inspection-ready pharmacovigilance environment.
Who you are:
• Medical, pharmaceutical, or healthcare background, or equivalent relevant work experience
• Fluency in written and spoken local language and English
• Experience in the pharmaceutical industry or with health authorities, including 2–3 years in patient safety
• Good knowledge of local pharmacovigilance regulations
• Good understanding of drug development and lifecycle management
• Strong intercultural skills developed through practical experience
• Strong teamwork skills, including working across cultural and functional boundaries and participating in virtual teams
• Good problem-solving and decision-making abilities
• Good organizational skills, with the ability to prioritize work and adapt quickly to changing priorities
• Ability to manage multiple situations and issues under time pressure
• Effective presentation and training skills
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 438 comparable Regulatory Affairs roles across 98 biopharma companies.
Salary context
119 of 438 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 438 comparable roles
+ 46 more countries
Seniority mix
348 of 438 peers have a known seniority level
Therapeutic area mix
36 of 438 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Currently open similar roles
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How we calculate "similar"
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.