Medical Safety Officer

Job Description:

Core Purpose of Role:

Reporting to the Medical Safety Manager, the Medical Safety Officer serves as the primary liaison for the company's global pharmacovigilance efforts across its range of investigational products.
Responsibilities include ensuring operational compliance in clinical trials, overseeing Pharmacovigilance vendors, and contributing to adherence to Pharmacovigilance regulations.

Key Responsibilities:

Ensuring compliance with pharmacovigilance operational processes in assigned projects.
Collaborating with external service providers to handle Individual Case Safety Reports (ICSRs) from clinical trials and ensuring expedited reporting requirements are met.
Coordinating the development of study-specific Safety Project Plans for assigned clinical studies and overseeing their execution.
Managing the development and submission of Development Safety Update Reports (DSURs).
Ensuring adherence to regulatory requirements and timely submission of expedited and periodic reports.
Overseeing the pharmacovigilance aspect of the electronic Trial Master File (eTMF) in collaboration with Clinical Operations.
Collaborating with Quality Management to ensure operational processes align with the company's model.
Working with external service providers to ensure pharmacovigilance services meet industry standards and regulatory guidelines.
Contributing to the creation and review of safety-related documents for clinical studies.
Representing the Medical Safety Department in cross-functional meetings or working groups as necessary.

Job Requirements:

Education & Experience:

A Pharmacist or a degree in Life Sciences
At least 3 years of experience in a similar position, including working in a structured environment as a member of program/compound teams, preferably in a biotech or pharmaceutical company
Experience in drug development
Experience in a matrix environment, with the ability to interact with stakeholders from various backgrounds and adapt to corporate culture

General Skills:

A broad understanding of pharmacovigilance needs within a drug development environment Solid knowledge of the drug development process Familiarity with ICH (International Council on Harmonisation of Technical Requirements), GCP (Good Clinical Practice), and other regulatory requirements relevant to pharmacovigilance
Excellent team player, capable of meeting tight deadlines in a demanding environment Strong technical and organizational skills

Communication Skills:

Excellent written and verbal communication skills, both internally and externally Negotiation and influencing skills

Language Skills:

Fluency in English, proficiency in other international languages is advantageous.