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Company

Apogee Therapeutics · 2 days ago

Director Global Safety and PV Operations

United States

Full-time

Remote

Director/Executive

$210K/yr - $245K/yr

8+ years exp

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BiotechnologyLife Science

No H1B

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Responsibilities

Manages all operational aspects of pharmacovigilance

Proactively oversees creation and continuous improvement of adverse event reporting and management processes on a global scale, including the oversight of the case management and regulatory submissions activities

Leads safety review meetings and oversees global signal detection and surveillance activities for assigned Apogee products

Partners with vendors for resolution of safety operational issues and questions, identifying vendor training needs and opportunities for improvement and ensuring implementation in collaboration with Apogee stakeholders

Accountable for effective oversight of outsourced operational activities, measuring vendor performance through Key Performance Indicators/Metrics according to Apogee standards and contracted Service Level Agreements(s)

Oversees the appropriate management of safety management plans (SMP) and other operating procedures with business partners as required

Provide direction and leadership regarding safety vendor management

Assist in management of all critical departmental timelines and with budgets for internal and external spend

Plan and oversee the implementation of database reconciliation in collaboration with Data Management and Apogee business partners as required

Ensure appropriate documentation by identifying and preparing required written procedures

Provide operational input into PV SOPs and reviews SOPs from other functions

Maintain aggregate report schedule, ensure proper SOPs are in place and current to support aggregate report production

In collaboration with Regulatory Affairs, provide information to be submitted to Regulatory Authorities, maintain and update regulatory reporting rules, ensure timely submission of expedited safety reports, and ensure that submission information is tracked in the safety database

As required, participate in strategic planning, workflow development, standard operating procedure updates, development & compliance, audits, data analysis and clinical team meetings

Identify opportunities for process efficiencies and participate in process improvement initiatives

Provide support to the Quality team and support product complaint activities as needed

Ensure compliance with FDA regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements

Qualification

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Pharmacovigilance operationsRegulatory complianceSafety reportingDrug safety databasesFDA guidelinesICH guidelinesCross-functional team leadershipMedDRAAggregate report requirementsIndividual Case Safety ReportsWorkload planningProject management

Required

Bachelor’s degree in life sciences or related area

Minimum 8 years of pharmaceutical experience with a demonstrated focus in PV operations and compliance

At least 4 years of experience in leading cross-functional teams and/or PV related deliverables and initiatives

Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA

Thorough knowledge of relevant FDA and International Conference on Harmonization (ICH) guidelines required, including Good Clinical Practices (GCP) guidelines

Thorough understanding of Individual Case Safety Reports (ICSR) processing operations required, including working with outsourced vendors and Contract Research Organizations as well as all steps through case receipt, case processing, medical review, and regulatory submission, issuing follow up queries, etc.

Solid knowledge of safety surveillance and aggregate report requirements for clinical trials

Demonstrated technical, administrative, and project management capabilities

Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills

Adaptable to changing priorities

Proven ability to work in a cross-functional team environment

Successfully exhibit Apogee’s O.R.E. values: Caring, Original, Resilient and Egoless

Position requires approximately 15% travel to All Team meetings and functional meetings

Preferred

Master’s degree or higher

Working knowledge and experience with European pharmacovigilance regulations

Benefits

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits

Flexible PTO

Two, one-week company-wide shutdowns each year

Commitment to growing you professionally and providing access to resources to further your development