Associate Director, Pharmacovigilance Operations
About the position
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, ensures 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.
Responsibilities
• Day to day vendor oversight activities including adverse event intake case management, management of safety inbox, vendor's performance, training on relevant ITF conventions and SOPs, responding to issues from daily activities
• Ensures timely transmission of AE reports to global pharmacovigilance team
• Ensures reconciliation of post-marketing reports with relevant internal and external partners are completed in a timely manner
• Respond to vendor questions regarding products 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
• Management of 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
Requirements
• 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
Nice-to-haves
• Bachelor’s degree in pharmacy, nursing, life sciences, or healthcare field
• PharmD or advanced degree in nursing, pharmacy, or healthcare field preferred
• Experience working with international regulating 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
Benefits
• 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
Apply To this Job
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, ensures 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.
Responsibilities
• Day to day vendor oversight activities including adverse event intake case management, management of safety inbox, vendor's performance, training on relevant ITF conventions and SOPs, responding to issues from daily activities
• Ensures timely transmission of AE reports to global pharmacovigilance team
• Ensures reconciliation of post-marketing reports with relevant internal and external partners are completed in a timely manner
• Respond to vendor questions regarding products 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
• Management of 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
Requirements
• 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
Nice-to-haves
• Bachelor’s degree in pharmacy, nursing, life sciences, or healthcare field
• PharmD or advanced degree in nursing, pharmacy, or healthcare field preferred
• Experience working with international regulating 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
Benefits
• 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
Apply To this Job