Regional Pharmacovigilance Officer

The Regional Pharmacovigilance Officer is responsible for specified activities that support the Pharmacovigilance Country Lead and Pharmacovigilance Regional Lead.
Country level audits and inspections, aggregate safety report distribution, health authority submission compliance (individual case safety reports and aggregate safety reports), local and regional contractual pharmacovigilance agreements, training tracking, and case work (if needed) with countries. As requested by the GS Regional Leads, the Regional Pharmacovigilance Officer may undertake other additional activities including projects and back-up activities for a Pharmacovigilance Country Lead.
The Regional Pharmacovigilance Officer routinely interacts with the Pharmacovigilance Regional Leads, Pharmacovigilance Country Operations staff and Global Safety Headquarters staff, as well as colleagues from Global Clinical Trial Operations, Global Regulatory Affairs, Global Medical Affairs and other business units. Some travel may be required.
The position reports to the Pharmacovigilance Regional Director in Latin America
Functional competencies
knowledge of pharmacovigilance principals, concepts, systems & requirements
Awareness of local industry code(s) of practice
Knowledge of the local pharmacovigilance regulations & obligations
Basic understanding of Good Clinical Practice concepts
Understanding of regulatory & compliance management
Ability to analyze & interpret data
Rapid, disciplined decision making
Collaboration & partnering ability
**Skills**:
Communication
Excellent written & spoken English
Strong presentation skills
Ability to communicate effectively verbally and in writing
Proficient in Good Documentation Practices
Familiarity with a safety database
Ability to learn new computer interface systems
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
**Employee Status**:
Regular
**Relocation**:
No relocation
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**: R

---