Medical Safety Lead (m/w/d) - Biosimilars - #2077129

For our client, a global leader in generic pharmaceuticals and biosimilars, we are seeking a dedicated and experienced Medical Safety Lead for the Biosimilars division, based in Munich. This role is critical to ensuring the safety and efficacy of the biosimilar products throughout their lifecycle.

Key Responsibilities:

• Lead and manage all aspects of drug safety and pharmacovigilance activities for biosimilar products.
• Develop and maintain Risk Management Plans (RMPs) and ensure their implementation.
• Monitor and evaluate safety data from various sources to identify potential safety signals.
• Provide expert medical safety input into clinical development programs, regulatory submissions, and post-marketing activities.
• Collaborate with cross-functional teams, including regulatory affairs, clinical development, and medical affairs, to ensure a cohesive approach to product safety.
• Communicate safety issues to internal and external stakeholders, including regulatory authorities.
• Oversee the preparation and submission of periodic safety update reports (PSURs) and other safety-related documentation.
• Ensure compliance with global regulatory requirements and company standards.
  
  

Qualifications:

• Medical degree (MD) or equivalent qualification.
• Extensive experience in drug safety/pharmacovigilance, particularly with biosimilars.
• In-depth knowledge of global pharmacovigilance regulations and guidelines.
• Strong analytical skills with the ability to interpret complex safety data.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a cross-functional, multicultural environment.
• Proficiency in English; additional languages are a plus.
  
  

The Offer:

• An opportunity to work with a leading company in the pharmaceutical industry.
• A dynamic and supportive work environment.
• Professional development and career growth opportunities.
• Competitive salary and benefits package.
  

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