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Job Details

Principal Pharmacovigilance Scientist

Company: Edelway Switzerland AG
Location: Basel area
Reference: D-008
Closing Date: 29 Dec 16
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Edelway is a pan-european Pharma Consultancy. One of our best client, a global, pharmaceutical company based in Basel Area is currently looking for experienced Principal Pharmacovigilance Scientist.

Requirements:

Descriptions:

The Principal Pharmacovigilance (PV) Scientist role provides expertise to multiple and/or single but complex products in different stages of development as needed. He/she provides oversight of safety documents and deliverables for these projects in collaboration with the Global Safety Physician (GSP) and other PV Scientists. He/she leads PV strategy for safety documents and regulatory reports.

Main Responsibilities:

  • Leads the strategy for proactive pharmacovigilance and risk management planning of complex or multiple products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.
  • Provides subject matter expertise in the therapeutic area and across multiple products.
  • Has the ability to lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organization.
  • Performs duties as a Safety Strategy and Management Team (SSaMT) Leader for complex and/or multiple products.
  • As a Safety expert leads presentation of complex issues to Safety Information Review Committee (SIRC).
  • Leads safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
  • Leads safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
  • Leads negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.
  • Takes accountability and leads resolution of complex safety issues and mediates cross-functional agreement.
  • Has the ability to participate in due diligence activities.

Essential

       A life sciences/pharmacy/nursing degree, with at least 7 years Patient Safety and/or Clinical or Drug Development experience, with a background and demonstrable strategic ability working cross-functionally within pharmacovigilance, medical information, medicines management, pre-clinical or clinical research. This experience should include safety surveillance, aggregate reporting, and analytics.

  • Proven leadership skills, able to resolve conflict and think/influence strategically.
  • Able to work with a high degree of autonomy and effectively as a member of a cross-functional or global team.
  • Demonstrable professional excellence -- adds value by applying expertise proactively.
  • Good attention to detail.
  • Good time management.
  • Fluent in English.
  • Computer literate.
  • Comprehensive understanding of Patient Safety regulatory obligations.

Desirable

  • MSc/PhD in scientific discipline.
  • Good understanding of epidemiologic data.
  • Proven good communication skills with ability to work across cultures.
  • Able to influence whilst maintaining independent and objective views.
  • Experience of mentoring or supervising Patient Safety colleagues.
  • A comprehensive understanding of how their role within the function contributes to the overall business.

 

If this sounds like your next challenge please send us your CV at “pharma@edelway.com“ or contact us at +34 93 018 5722.

Apply for this job: Principal Pharmacovigilance Scientist

Contact Information:

Address:  Head Office
Sihleggstrasse 23 8832 Wollerau

Switzerland
Tel:  +41 58 717 7000
Website:  Visit Our Web Site

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