Senior Specialist

**Job Description**:
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

As an addition to our Team and based in Munich, we are looking for a Senior Specialist (M/F/d) Drug Safety / Pharmacovigilance (permanent full-time contract).

**Your responsibilities**:

- Responsible for execution of local PV processes and activities
- Provides support for Patient Support Programs (PSP) and/or Market Research vendor(s) related activities, as applicable
- Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues
- Serves as Subject Matter Expert and supports local PV audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations
- Participates in and supports audits of contractual partners/vendors as necessary
- Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders
- Supports with the training of PV of local company staff as wells as vendors and business partners including training documentation
- Liaises with the local business units to keep them apprised of safety activities and provide input on strategic decisions
- Responsible for day-to-day adverse events case management including case intake and follow-up activities
- Accountable for the intake of cases received from the designated point of contact, Vendors, and Business Partners for Individual case safety reports (ICSRs) including tracking and translation to English as well as forwarding of information to the Data Management Center

**Your profile**:

- Health, life science, medical science degree or equivalent
- Minimum 3 years of industry experience in Pharmacovigilance
- Project Management experience
- In-depth knowledge of AE reporting requirements and relevant PV regulations, PV quality management systems and advanced knowledge in PV processes and activities
- Experience with PV audits and/or PV Health Authority Inspections
- Collaboration and partnering skills
- Problem solving, strategic thinking and decision-making skills
- You are authentic, empathetic, curious and courageous
- Above average and advanced Microsoft Office Skills
- Highly proficient in spoken and written German and English (minimum B2 level) and excellent communication skills
- A full Covid 19 vaccination is required (- 20a IfSG)*

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.

People with severe disabilities and their equivalents will be given preference if they are equally qualified.
- **Disclaimer**:
**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
Domestic/International

**VISA Sponsorship**:
No

**Travel Requirements**:
No Travel Required

**Flexible Work Arrangements**:
Hybrid

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