Director, Safety

New York
Our client is a clinical-stage biotechnology company. They have asked us to assist in their search for an Executive Director/Vice President, Pharmacovigilance/Global Safety Lead.  

Major tasks and responsibilities will include:
  • Leads aggregate safety data reviews and the preparation of the medical content, periodic reports (including PSURs, DSURs) and ad-hoc reports.
  • Ensures that the safety profiles of products are accurately and consistently represented in relevant labeling documents.
  • Leads the preparation and delivery of high quality, consistent and compliant safety information for regulatory submission documents (including IND and NDA).
  • Oversees the development of relevant medical sections of responses to safety related health authority requests as well as clinical documents such as IBs, clinical protocols, safety management plans, study reports, and integrated analyses.
  • Organizes and conducts quarterly Medical Safety Board meetings to review aggregate safety information and signal management for all products.
  • Oversees medical review of individual case safety reports (ICSRs).
  • Identifies opportunities and manage continuous improvement initiatives as related to medical assessment of pharmacovigilance data.
  • Prepares, summarizes, and reviews aggregate safety analyses. Additionally, this position develops and implements integrated project/product risk management strategies and drafts the Risk Management Plan with Level III. This position performs safety assessments and determines the safety profiles of assigned products.
  • Medical safety reviews of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the product life cycle for assigned products. Medical reviews of adverse event reports include assessment for seriousness, expectedness, appropriate coding and causality; deciding on necessary follow-up queries for individual cases.
  • Conducts signaling activities, including monitoring, evaluation, interpretation, management and communication of safety information.
  • Leads the Product Safety Teams for assigned products and manages benefit-risk profiles along with the related actions, including writing and updating of the benefit-risk documents for assigned products and development compounds.
  • Medical expert safety reviews of and inputs into all critical documents for assigned products in clinical development (e.g., protocols and -amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs, DSURs).
  • Collaborates with the CMO to develop and implement the strategy for benefit-risk management for assigned products.
  • Authors important medical content of Risk Management documents (e.g., RMPs, REMS).
  • Writes periodic reports for assigned products and provides medical interpretation, review and approval for required reports where applicable.
  • Provides expert safety input into clinical development programs for assigned products.
  • Ensures, in collaboration with Regulatory Affairs labeling review team an accurate representation and communication of the safety profile of assigned products by the Product’s Reference Safety Information, including the Company Core Safety Information (CCSI), the Investigator Brochure, and local labeling documents.
  • Provides the medical safety content for responses to inquiries from regulatory authorities related to safety topics and integrated safety input into any applicable regulatory documents where required.
  • Provides Drug Safety input for individual product quality complaints, aggregate product quality associated Health Hazard Evaluations, product recall issues and Dear Healthcare Professional letters/communications.
  • Reviews scientific literature for assigned products, identifying case reports that meet criteria for entry into the safety database; identifies relevant safety articles / references involving the active ingredients of the assigned products; and creates literature summary sections for PBRERs/PSURs and other required reports.
  • Develops and maintains strong relationships and shares drug safety and general medical expertise within assigned therapeutic areas with other stakeholders including Clinical Development Teams, Regulatory Affairs, Licensing and Marketing to better understand and fully support business objectives.
  • Provides applicable medical safety input to clinical team decisions.
  • Participates in inspection readiness activities as it pertains to assigned products and PV related activities for assigned products.
  • Continuously accrues therapeutic area knowledge to allow for ongoing safety assessment within the therapeutic area, including competitive products and therapies.
We seek candidates with the following qualifications:
  • Medical degree or DO equivalent is required.
  • Requires a minimum of 8-12 years clinical/practical experience in a relevant clinical environment.
  • Must have a minimum of 2 years of Pharmacovigilance experience in Clinical Safety including thorough knowledge of FDA and ICH safety reporting regulations and guidelines.
  • Experience with regional, national and global regulatory authority is a preferred.
  • Must have strong oral and written communication skills.
  • Advanced analytical skills are required.
  • Requires sound medical judgment and decision-making capabilities.
  • Strategic thinking and facilitative leadership are required.
  • Must have fluent utility of office computer programs such as Excel, Word, and PowerPoint.
  • Requires sound organizational and prioritization skills.
  • Formal training in Epidemiology is strongly preferred.
  • Must have demonstrated skills for project management.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

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