GPS Safety Strategy Lead/Medical Director (m/w/d) – freelance – on hold

  • Position zu besetzen ab 1. Januar 2020
  • Permanent-ID OCR-FL-885
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 6x
  • Kategorien Beschäftigungsform, Freelance/Contracting

The role of the Global Patient Safety Medical Director TA(s) Neurology & Immunology / Fertility & Biosimilar & Anti-malaria / General Medicine & Endocrinology is to ensure effective and proactive medical safety strategies for assigned development compound(s) and/or marketed product(s) in the field of mentioned above including risk management and benefit-risk assessment.

Task:

  • Identify and evaluate the risks and thereby contribute to defining the safety strategy
  • Provide a timely and accurate medical evaluation of individual and aggregated safety data from pre- and post-authorization sources, i.e. medical assessment for ICSRs, SUSARs
  • Ensure correct MedDRA coding of adverse events from assigned case reports
  • Prepare PSURs/PBRERs, medical assessment for other aggregated safety reports (e.g. EU ASR, 6-monthly SUSAR report
  •  Ensure the provision of a clearly defined safety strategy, in the context of delivering the benefit-risk profile, and ensure that plans in place are consistent with delivering this strategy
  • Ensure appropriate oversight of the emerging safety profile of the product, including medical review of individual case safety reports as required, signal detection and evaluation, periodic safety reporting, risk-benefit evaluation and risk management, and that any significant signals or safety issues are escalated appropriately within the company
  • Ensure delivery of safety aspects to clinical trial activities as appropriat
  •  Represent GPS at submission teams and provide safety strategic input into submission relevant documents including the Integrated Safety Summary (ISS) SAP, Integrated Summary of Safety, Clinical Summary of Safety (Module 2.7.4), Clinical Overview (Module 2.5) as well as safety update reports
  • Coach, support and help to develop the other GPS staff in the relevant GPS Product Team; chair the BRAT and SMCs as required
  • Represent GPS on cross-functional teams for the product, including e.g. the Global Product Team and any Alert Action Teams, ensuring that all negotiated and agreed deliverables and deadlines for these teams are met (may be delegated as appropriate)
  • Represent GPS on safety aspects for the product externally, e.g. engagement with
    SMCs/IDMCs, preparation for and attendance at regulatory authority meetings,
    interactions with external advisers or opinion leaders, collaboration with colleagues
    from partnership companies for co-development or co-marketing, etc.
  • Provide product- or TA-specific training to GPS colleagues, and safety training to
    non-safety colleagues, as required
  • Ensure effective communication of product-related aspects in audits and regulatory
    authority inspections
  • Provide medical safety expertise for due diligence activities as required

Skills:

  • Master Degree with clinical experience or Master of Science/PhD with work
    experience in pharmacovigilance area or several years of medical experience as
    a physician
  •  Broad industry experience (minimum 5 years), preferably including both clinical
    development and pharmacovigilance experience (including medical safety
    evaluation and safety decision-making based on clinical acumen and medical
    judgment)
  • Preferentially prior experience with NDA/BLA or equivalent regulatory submissions
    or working experience from a Regulatory Agency on reviewing submission files
  • Excellent medical judgment in safety decision-making
  • Strong, mature project leadership and influencing skills
  • Proven ability to chair meetings effectively
  •  Solution and results orientated
  • Willing to cope with resistance and problems; demonstrated ability to work under
    pressure and achieving strict timeline targets
  • Entrepreneurial thinking and striving to move project(s) forward, within budget and
    timelines
  • Languages: English (business fluent), German nice to have

Additional Information
Location: Darmstadt
Project start: 01.01.2020
Duration: ca. 1 year
Availability: 4 -5 days / week
On-site: tbd.
Remote: tbd.

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