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- Aufgaben: Lead drug safety and pharmacovigilance for biosimilars, ensuring product safety throughout their lifecycle.
- Arbeitgeber: Join a global leader in generic pharmaceuticals and biosimilars based in Munich.
- Mitarbeitervorteile: Enjoy a dynamic work environment with competitive salary and professional development opportunities.
- Warum dieser Job: Make a real impact on patient safety while collaborating with diverse teams in the pharmaceutical industry.
- Gewünschte Qualifikationen: Bring extensive experience in drug safety, strong analytical skills, and excellent communication abilities.
- Andere Informationen: Full-time position at mid-senior level with opportunities for career growth.
Das voraussichtliche Gehalt liegt zwischen 54000 - 84000 € pro Jahr.
Medical Safety Lead (m/w/d) – Biosimilars
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:
- 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.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Manufacturing
Industries: Pharmaceutical Manufacturing
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Medical Safety Lead (m/w/d) - Biosimilars Arbeitgeber: Progressive Recruitment
Kontaktperson:
Progressive Recruitment HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Medical Safety Lead (m/w/d) - Biosimilars
✨Tip Nummer 1
Nutze dein Netzwerk! Sprich mit ehemaligen Kollegen oder Kontakten in der Pharmaindustrie, die möglicherweise Informationen über offene Stellen oder Empfehlungen haben. Networking kann oft der Schlüssel sein, um in eine Position wie die des Medical Safety Lead zu gelangen.
✨Tip Nummer 2
Informiere dich über aktuelle Trends und Entwicklungen im Bereich Biosimilars. Zeige in Gesprächen oder Interviews, dass du über die neuesten regulatorischen Anforderungen und Sicherheitsstandards informiert bist. Dies wird dir helfen, dich von anderen Bewerbern abzuheben.
✨Tip Nummer 3
Bereite dich darauf vor, spezifische Beispiele aus deiner bisherigen Erfahrung zu teilen, die deine Fähigkeiten in der Pharmakovigilanz und im Risikomanagement demonstrieren. Konkrete Erfolge und Herausforderungen, die du gemeistert hast, können einen starken Eindruck hinterlassen.
✨Tip Nummer 4
Zeige deine interkulturelle Kompetenz! Da die Rolle in einem multikulturellen Umfeld stattfindet, ist es wichtig, dass du deine Fähigkeit zur Zusammenarbeit mit internationalen Teams hervorhebst. Betone deine Sprachkenntnisse und Erfahrungen in verschiedenen kulturellen Kontexten.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Medical Safety Lead (m/w/d) - Biosimilars
Tipps für deine Bewerbung 🫡
Research the Company: Familiarize yourself with the client’s mission, values, and recent developments in the biosimilars sector. This knowledge will help you tailor your application and demonstrate your genuine interest in the role.
Highlight Relevant Experience: Emphasize your extensive experience in drug safety and pharmacovigilance, particularly with biosimilars. Use specific examples to showcase your analytical skills and ability to interpret complex safety data.
Craft a Strong Cover Letter: Write a compelling cover letter that outlines your qualifications and explains why you are the ideal candidate for the Medical Safety Lead position. Make sure to address how your skills align with the key responsibilities listed in the job description.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any grammatical or typographical errors. A polished application reflects your attention to detail and professionalism.
Wie du dich auf ein Vorstellungsgespräch bei Progressive Recruitment vorbereitest
✨Understand the Role
Make sure you have a clear understanding of the responsibilities of a Medical Safety Lead, especially in the context of biosimilars. Familiarize yourself with drug safety and pharmacovigilance activities, as well as Risk Management Plans (RMPs).
✨Showcase Your Experience
Prepare to discuss your extensive experience in drug safety and pharmacovigilance. Highlight specific examples where you've successfully managed safety data or collaborated with cross-functional teams, particularly in a multicultural environment.
✨Demonstrate Analytical Skills
Be ready to explain how you interpret complex safety data. You might be asked to analyze a hypothetical scenario, so practice articulating your thought process and decision-making skills in relation to safety signals.
✨Communicate Effectively
Since excellent communication is key for this role, practice conveying complex information clearly and concisely. Be prepared to discuss how you would communicate safety issues to various stakeholders, including regulatory authorities.
