Apply on Employer Site

ITF Therapeutics LLC · 1 day ago

Associate Director, Pharmacovigilance Operations

Concord, MA

Full-time

Hybrid

Lead/Staff, Director/Executive

$195K/yr - $215K/yr

8+ years exp

ITF Therapeutics LLC is looking for an Associate Director of Pharmacovigilance Operations to oversee vendor management in post-marketing pharmacovigilance. The role involves ensuring compliance with pharmacovigilance systems and processes while collaborating with internal and external stakeholders to maintain patient safety and regulatory standards.

ManufacturingPharmaceuticalTherapeutics

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

Qualification

Pharmacovigilance expertiseVendor managementRegulatory complianceFDA knowledgeBachelor’s degreePharmDAdvanced degreeClear communication skillsLeadership abilitiesCollaboration skills

Required

8+ 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 in working with the FDA / US regulatory body

Preferred

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