Senior Specialist Drug Safety (m/f/d)

Merck Gruppe - MSD Sharp & Dohme; Schwabenheim an der Selz; Vor Ort; EUR 65.000 - 85.000; Vollzeit

Zusammenfassung

A pharmaceutical research facility in Schwabenheim seeks a Senior Specialist Drug Safety to join their Global Pharmacovigilance team. This full-time role involves overseeing case reviews, ensuring compliance with regulations, and participating in signal management activities. Ideal candidates possess a veterinary degree or equivalent and have experience in highly regulated environments. The position offers a hybrid working model, flexible hours, and a competitive salary package.

Leistungen

Flexible working hours

Attractive company pension scheme

30 days holiday entitlement

Corporate benefits

Good company canteen

Qualifikationen

• Veterinary degree or equivalent, preferably in applied natural science.
• Knowledge of pharmacology/toxicology or practical veterinary experience.
• Experience in a regulated pharmaceutical field, ideally pharmacovigilance.

Aufgaben

• Case review/approval for assigned products.
• Expedited case submission according to timelines outlined in regulations.
• PV Statement and PSUR preparation in compliance with regulations.

Kenntnisse

Adaptability

Communication

Data Analysis

Drug Safety Surveillance

Ausbildung

Veterinary degree or equivalent

Jobbeschreibung

Job Description

We are seeking a Senior Specialist Drug Safety (m/f/d) in Global Pharmacovigilance to join our team at our innovative research facility in Schwabenheim (near Mainz). This is a full-time position offered on a temporary contract basis for a duration of two years.

Main responsibilities:

• Case review/approval for assigned products

• Expedited case submission according to timelines outlined in applicable regulations

• Case entry for non-PV-Works countries for assigned products

• PV Statement and PSUR preparation in compliance with relevant regulations and policies

• Participation in signal management activities

Your profile:

• Veterinary degree or equivalent, preferably in applied natural science. Candidates without this degree but proven skills and experience to work at such level are also considered.

• Knowledge of pharmacology /toxicology or practical veterinary experience of advantage

• Experience in a highly regulated pharmaceutical field, ideally pharmacovigilance or regulatory affairs of advantage

• You combine strong analytical skills with communication and writing skills in an international environment

• Proficient in English

Our offer:

• Flexible working hours (37.5 hours/week) and an attractive company pension scheme

• Competitive salary package: 13 monthly salaries + holiday pay + target bonus

• 30 days holiday entitlement (depending on location)

• Hybrid working model

• Insights into the development of veterinary medicinal products

• Corporate benefits and free (electric) car parking

• Good company canteen and a company health management program

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Temporary (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Required Skills:

Adaptability, Adaptability, Adverse Event Report, Animal Handling, Applied Engineering, Auditing, Communication, Compliance Monitoring, Data Analysis, Decision Making, Drug Safety Surveillance, Global Sourcing, Global Supply Chain, Healthcare Innovation, Management Process, Pharmaceutical Regulatory Compliance, Pharmacodynamics, Pharmacokinetics, Pharmacotherapeutics, Pharmacovigilance, Pharmacy Regulation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Reporting, Risk Management {+ 5 more}

Preferred Skills:

Job Posting End Date:

08/6/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R357679