Drug Safety Specialist
hace 3 días
**Job Description**:
We invite you to join out team
We are currently recruiting a Pharmacovigilance Specialist. Under the direction of the applicable management, the PV Specialist is responsible for Country Pharmacovigilance activities (as delegated/assigned by their manager), which may include but are not limited to the Intake activities (including reconciliation and follow-up), aggregate submissions, compliance monitoring, management and negotiation of local Pharmacovigilance agreements, local due diligence activities, supporting audits and inspections and related readiness activities, authoring local Standard Operating Procedures', conducting local training, and archiving under supervision. The Pharmacovigilance Specialist may serve as the backup local Qualified Person for Pharmacovigilance / Local Pharmacovigilance Contact / Local Responsible Pharmacovigilance person as required per local Pharmacovigilance legislation. In the absence of the Pharmacovigilance Lead, they may manage day-to-day Pharmacovigilance activities and serve as their backup.
Education
- Bachelor’s Degree in Health, Life Science or Medical Sciences
Work Experience:
- A minimum of one (1) year of experience in the pharmaceutical industry with a specific focus on safety and pharmacovigilance-related activities.
- General knowledge of Adverse Events reporting requirements and relevant Pharmacovigilance regulations.
Job‐specific competencies & skills:
- Must be fluent in English (written and spoken) while proficient in the local language
- Ability to travel within the region and globally, up to 10% of the time.
- Effective interpersonal communications, organizational, time management, and presentation skills.
- Ability to work in partnership with others (internally and externally) to accomplish quality goals.
- Ability to interface broadly with colleagues within related functions and cross-functionally.
- Demonstrates skills to drive change that enhances processes within the company or cross-functionally that improve quality and /or add value to the business.
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., Rahway, 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**:
10%
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R220815
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