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Find out how this Senior Drug Safety Advisor is revolutionizing global safety surveillance and protecting patients

Senior Drug Safety Advisor Jobs

Senior Drug Safety Advisor Jobs At LEO Pharma, They help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. You will join Global Safety Surveillance which consists of 2 teams both working with products in all phases of the drug life cycle and striving to safeguard our patients. We are an ambitious team driven by a high level of integrity, science, and passion for our work. We value a great collaborative atmosphere where you can always reach out to a colleague or manager for support and sparring.

Job Position: Senior Drug Safety Advisor

Field of work: Clinical Development

Job ID: 1522

Location: Gdańsk 80-309, Poland

Contract type: Permanent

Role Description

Are you ready to take your career to the next level and develop in a role that will allow you to manage the global safety profile for post marketed products?

LEO Pharma has embarked on an ambitious journey to become the preferred dermatology care partner improving people’s lives around the world – and that is why we need you.

Your role

Your overall objective will be to ensure continuous safety surveillance of marketed compounds/products.

Your main tasks will be to:

  •  Provide overall safety surveillance for assigned products, on an on-going basis
  • Conduct medical evaluation/review of Adverse Events reports, Summary of Product Characteristics, Company Core Safety Information, patient information leaflets and other safety information
  •  Write and review aggregated safety reports, Risk Management Plans, safety sections required in documents such as CCSI/core SmPC and other relevant safety reports
  •  Conduct signal detection and management
  • Prepare PV specific documents for regulatory submissions
  • Ensure correct medical evaluation of safety information (e.g. adverse events) from all LEO products

Your qualifications

To succeed in this role, we imagine that you have the following qualifications:

  •  University degree in health or biological science (MD, MSc, MSc Pharm, or equivalent
  •  At least 4-year experience working in a project oriented, international organization preferably in pharmacovigilance
  •  Strong medical/scientific knowledge/evaluation knowledge
  •  Solid knowledge of global (EMA/FDA/ICH) regulatory requirements
  •  Strong data analysis and interpretation skills
  •  Medical and scientific writing skills
  •  Fluent verbal and written English
  • Strategic thinking, influencing, and collaboration

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Shekhar
Shekhar
Shekhar Suman is the Co-founder of BioTecNika Info Labs Pvt. Ltd. He is an Entrepreneur, Writer, Public Speaker, and a Motivational Coach. In his career, he has mentored more than 100,000+ students toward success in the Biopharma Industry. He heads the BioTecNika Group, which comprises BioTecNika.com, BioTecNika.org, and Rasayanika.com. An avid reader and listener who is passionate about BioSciences. Today Biotecnika is India's largest Biotech Career portal, with over 5 Million subscribers from academia & Industry. It's ranked among the top 50 websites worldwide in the Biology category.
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