Associate Director, Pharmacovigilance Operations

Associate Director, Pharmacovigilance Operations

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Reports To:

Senior Director, Pharmacovigilance Operations

As part of the pharmacovigilance operations team, you will play a key role in the day-to-day vendor oversight of our post‑marketing PV vendor, ensuring the highest quality information is provided in a timely manner. In partnership with the US Head of Pharmacovigilance/Local Safety Officer, you will ensure that appropriate pharmacovigilance (PV) systems and processes are in place for the US organization in alignment with the global and local PV strategy and requirements.

This role will be hybrid, so candidates applying must be willing and able to come to our office in Concord, MA on a weekly basis.

• Day‑to‑day vendor oversight activities including adverse event intake case management, management of safety inbox, vendor performance, training on relevant ITF conventions and SOPs, responding to issues from daily activities
• Ensures timely transmission of AE reports to the global pharmacovigilance team
• Ensures reconciliation of post‑marketing reports with relevant internal and external partners is completed in a timely manner
• Respond to vendor questions regarding product case management conventions, etc.
• Collaborate with internal stakeholders and partnered vendors to identify improvement areas
• Lead the coordination and oversight of PV Awareness training for internal staff and applicable vendors/partners, utilizing the learning management system and providing live training when required to support compliance
• Manage vendor relationship and relationship documents
• Proactively partner with legal, commercial teams and other relevant stakeholders to review and ensure appropriate PV language is incorporated into contracts with applicable vendors and third parties

Working with our fast‑paced, growing team, you bring post‑marketing pharmacovigilance expertise to ensure vendor oversight meets the highest standards. With a sharp eye for compliance and detail, you have the ability to manage multiple priorities, while remaining consistently focused on patient safety.

• 8–10+ years of relevant and progressive experience in pharmacovigilance and/or regulatory compliance in the biotech and/or pharmaceutical industry
• Demonstrated track record of managing PV service providers, including 4+ years of relevant experience
• Strong foundation with FDA and progressive experience with international pharmacovigilance regulations

• Bachelor’s degree in pharmacy, nursing, life sciences, or healthcare field
• Pharm
  
  D or advanced degree in nursing, pharmacy, or healthcare field preferred
• Experience working with international regulatory bodies, including EMA or MHRA
• Proven track record working in a high‑paced, globally matrixed environment
• Demonstrated ability to initiate and lead department initiatives
• Clear and strategic communication skills to engage PV leadership, key stakeholders, and external partners to drive alignment and organizational objectives

The base compensation range for this role is: $195,000 – $215,000. Compensation is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

• Medical, Dental & Vision Insurance:
  Nationwide coverage with flexible plan options tailored to your needs
• 401k Company Match
• 100% Paid Bonding Leave:
  Dedicated time to support growing families
• Disability & Life Insurance:
  Multiple coverage options to protect what matters most
• Professional Development:
  Ongoing opportunities to grow your skills and career
• Flexible Time Off Package:
  Recharge and refresh with generous paid time off
• Additional perks to support your well‑being