Pharmacovigilance Specialist

**Job Description**:
The **Specialist **Pharmacovigilance** is responsible for pharmacovigilance activities (as delegated/assigned by their manager) which may include but is not limited to pharmacovigilance Intake activities (including reconciliation and followup), Individual case safety report (ICSR) and 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 Operational Procedures, conducting local training, and archiving and is able to perform these tasks with mínimal supervision.

The Specialist may serve as the Back-up local Qualified Person for Pharmacovigilance matters. In the absence of the Pharmacovigilance Lead, they may manage day-to-day Pharmacovigilance activities and serve as their back-up.

**Responsibilities**:

- Responsible for execution of local Pharmacovigilance (PV) processes and activities in collaboration with internal functional areas and external parties as assigned.
- Responsible for day-to-day adverse events case management including case intake, tracking, translation to English (as applicable), acknowledgments, and follow-up activities in accordance with PV procedures and country regulations.
- Responsible for reporting adverse experiences or events (AE) or product quality complaints (PQCs) associated with the use of our company products in compliance with Corporate Policy
- May coordinate translation of PV documents and ensure a Quality Control check is performed by a second person for any in-house translations (as applicable).
- Supports local PV audits and inspections including readiness activities and supports audits of business partners/vendors
- Participates in compliance activities and coordinates the preparation of necessary corrective actions locally for late reports.

**Position Qualifications**:

- Health, life science, or medical science degree or equivalent by education/experience
- Minimum 2 years of Experience in the pharmaceutical industry in Pharmacovigilance roles.
- General knowledge of adverse experiences or events (AE) reporting requirements and relevant PV regulations is preferred, but is not required
- Must be fluent in English/C1 (written and spoken)
- Preferable knowledge of Power BI tool.

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.**

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**Employee Status**:
Project Temps (Fixed Term)

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R222965