Permanent

Senior Medical Director, PV

Salary£290000
LocationBoston, Massachusetts, United States
SectorPharmaceuticals & Biotechnology

Description

The Company:

Concilium are partnering with a small, rapidly growing oncology company based in Massachusetts. The company is developing novel, first in class agents and has recently received FDA approval for their first product.

The Role:

The Senior Medical Director, Pharmacovigilance (PV) will provide broad support of activities requiring medical safety input for assigned products, pre- and post-approval. He/she will support and/or lead periodic safety signaling reviews and meetings, as well as perform individual and aggregate case review. He/she will also participate, in varying degrees, on clinical teams/programs and other intra and/or inter-departmental activities and initiatives.

  • Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
     
  • Provide timely and sound medical review of individual case safety reports from clinical trials or post-marketing sources as needed.
     
  • Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
     
  • Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
     
  • Lead preparation and review of periodic reports (IND, Annual Safety, DSUR, PBRERs, CSR). • Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter.
     
  • Participate in departmental development activities including SOP and Work Instructions development.
     
  • Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
     
  • Provide a contributory role in Partner /Affiliate agreements and interactions, as needed.
     
  • As directed by the PV Head, assume primary responsibility/chair for the conduct of one or more Safety Team(s) for assigned products.
     
  • Lead the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices.
     
  • Provide Risk Management Strategy.
     
  • Other activities, as needed or as requested by manager.

Your background:

  • MD, DO or equivalent ex-US medical degree.
     
  • Minimum of 8 years' expereince in Drug Safety/Pharmacovigilance or Medical Monitor experience.
     
  • Solid knowledge of General Medicine, MD, DO, MBBS.
     
  • Adequate knowledge of GCP, ICH and Global regulations.
     
  • Experienced in the evaluation and interpretation of data.
     
  • Ability to multi-task.
     
  • Solid written and oral communication skills.
     
  • Solid judgment and decision-making skills, including the identification and communication of relevant safety- related issues or concerns to Medical Safety Management in an appropriate and timely manner.
     
  • Experienced in safety reviews of AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents.
     
  • Close attention to detail.
Apply Today

Related Jobs

You may also be interested in these similar roles
  • Salary
    Competitive
    Location
    Netherlands
    Sector
    Pharmaceuticals & Biotechnology
    A leading biotech client of ours in the Netherlands are looking for a GMP Documentation Lead to...
  • Salary
    Competitive
    Location
    Belgium
    Sector
    Pharmaceuticals & Biotechnology
    Requirements:  In-depth knowledge and understanding of Human Resources legislation/employment...
  • Salary
    Competitive
    Location
    Limburg, Netherlands
    Sector
    Pharmaceuticals & Biotechnology
    (Key Accountabilities) Work to identify efficiencies in the validation program approach. Work to...
  • Salary
    Competitive
    Location
    Belgium
    Sector
    Pharmaceuticals & Biotechnology
    We are currently partnered with a leading pharmaceutical company located in Belgium who are looking...
  • Salary
    Competitive
    Location
    United Kingdom
    Sector
    Pharmaceuticals & Biotechnology
    Concilium Search are partnered with a leading, international API CDMOs serving the pharmaceutical...
  • Salary
    Competitive
    Location
    Dublin, Ireland
    Sector
    Pharmaceuticals & Biotechnology
    The Qualified Person (QP) is responsible for undertaking the necessary training prior to application...
  • Salary
    Competitive
    Location
    Netherlands
    Sector
    Pharmaceuticals & Biotechnology
    We are currently partnered with a world-leading contract manufacturing organisation, who have an...