Associate Director, Safety and Compliance (RFP) at ClinChoice

, , United States -

Full Time

Start Date

Immediate

Expiry Date

23 Dec, 25

Salary

0.0

Posted On

24 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Proposal Development, Client Support, Costing Development, Cross-functional Coordination, Process Improvement, Analytical Skills, Organizational Skills, Interpersonal Skills, Communication Skills, Regulatory Knowledge, Safety Services, Writing Skills, MS Office Proficiency, Budget Creation, Operational Forecasting

Industry

Pharmaceutical Manufacturing

Description

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 #LI-PB1 #LI-Remote

Responsibilities

The Associate Director will support the preparation and delivery of proposals related to pharmacovigilance and drug safety services. This role involves collaborating with business development teams and ensuring proposals meet client safety requirements and regulatory expectations.