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Associate Director, Safety and Compliance (RFP)

United States

Job Title: Associate Director, Safety and Compliance (RFP)

Department: Safety

Location: Remote

Report To: Head of Safety Operations

Position Summary:

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 stakeholders—such as regulatory, medical writing, finance, and legal—to 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.

#Pharmacovigilance#PV#Safety#RFP

 

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