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Associate Director, Safety and Compliance (RFP)

Associate Director, Safety and Compliance (RFP)

ClinChoiceWashington, DC, US
30+ days ago
Job type
  • Full-time
Job description

Associate Director, Safety and Compliance

We are seeking a proactive and detail-oriented Associate Director, Safety and Compliance to support the preparation and delivery of high-quality proposals, bids, and RFP responses related to pharmacovigilance (PV) and drug and medical device safety services. This role will bridge the gap between client-facing business development efforts and internal pharmacovigilance teams, ensuring that technical, operational, and costing components of proposals align with client safety requirements and regulatory expectations.

Key Responsibilities :

  • Client & Opportunity Support :
  • Collaborate with business development and client-facing teams to support pharmacovigilance-related RFPs and study bids.
  • Analyze and interpret client requirements specific to safety services, ensuring an accurate understanding of scope, deliverables, and timelines.
  • Act as the designated Safety RFP Lead for assigned RFPs or client accounts, representing the pharmacovigilance function during bid strategy discussions and proposal development.
  • Prepare and lead RFP slides proposal initiatives and coordinate with Pharmacovigilance team for the needed information.
  • Proposal & Costing Development :
  • Draft detailed safety costing proposals for assigned projects, in alignment with client specifications and organizational business strategies.
  • Draft, develop, and review proposal documents, including RFPs, RFIs, and bid presentations, ensuring consistency, accuracy, and clarity.
  • Modify or develop safety-related proposal workflows, optimizing efficiency and alignment with current PV processes.
  • Cross-functional Coordination :
  • Coordinate with the assigned safety team to validate operational and resource requirements for each proposal.
  • Liaise with other internal stakeholderssuch as regulatory, medical writing, finance, and legalto collect and integrate proposal content.
  • Ensure alignment across all functional inputs to support timely, competitive, and high-quality submissions.
  • Process Improvement :
  • Maintain and continuously improve templates, cost models, and standard proposal content for pharmacovigilance services.
  • Support the creation or enhancement of internal processes and documentation related to safety proposal generation.

Qualifications :

  • Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field (Master's or PharmD preferred).
  • 5 years of relevant experience in pharmacovigilance operations, with direct exposure to proposal / bid development strongly preferred.
  • Solid understanding of global PV and safety regulations (e.g., FDA, EMA, ICH).
  • Experience supporting safety proposals or bids in a CRO or pharmaceutical environment.
  • Strong writing, analytical, and organizational skills.
  • Proficiency in MS Word, Excel, PowerPoint; experience with pricing or proposal management tools is an advantage.

    • Preferred Skills :

  • Familiarity with safety databases (e.g., Argus, ARISg) and PV workflows.
  • Understanding of costing structures, budget creation, and operational forecasting for safety services.
  • Excellent interpersonal and communication skills; ability to influence across functional teams.
  • Ability to manage multiple concurrent deadlines and prioritize in a fast-paced environment.
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    Associate Director Compliance • Washington, DC, US