Manager, Pharmacovigilance Operations

Overview

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. We imagine a world where cancer is a curable disease. 

 At Replimune, we live by our values: 

United: We Collaborate for a Common Goal. 

Audacious: We Are Bold and Innovative. 

Dedicated: We Give Our Full Commitment. 

Candid: We Are Honest With Each Other. 

People are at the center of everything we do, and when it comes to our employees, we make it personal.  With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients.  

 Join us, as we reshape the future. 

Job Summary: 

The Manager, Pharmacovigilance Operations will report to the Director, Pharmacovigilance, Global Drug Safety & Risk Management and be involved with global pre- and post-marketing drug operational activities and will be responsible for assuring the processing and reporting of safety reports is following Replimune’s SOP's, guidelines, and worldwide pharmacovigilance regulations. This position must effectively interface cross-functionally at all levels in the organization, as well as externally with vendors and corporate partners.

This position is based in our Woburn office and welcomes hybrid work! Employees are expected to be on-site 2 days per week. 

Responsibilities

• Participates in the daily management of safety vendor providers.
• Ensure compliance with appropriate Regulatory Authorities to meet regulatory requirements.
• Project manage with the preparation of aggregate safety reports such as the Development Safety Update Report, Periodic Benefit Risk Evaluation Report, periodic line listings, safety assessments, ad-hoc analyses, as assigned.
• Performs case processing oversight activities from triage to case closure.
• Ensure SAE reconciliation is done in collaboration with data management team and any vendors as required.
• Oversight of safety data exchange with corporate partners to ensure compliance. with contracts and agreements related to safety case processing and reporting
• Participates in inspections and audits including inspection readiness activities.
• Supports department initiatives on ad hoc basis.
• Assists in creation of PV related training materials, Investigator and site training documents, authoring of PV SOPs and work instructions.
• Identify opportunities for process efficiencies and participates in process improvement initiatives.
• Facilitates and ensures communication with departments that may be involved with receiving, investigating or reporting of SAEs.
• Collaborates and provides pharmacovigilance guidance and support to cross-functional teams.

Other responsibilities:

• Other responsibilities as assigned.

Qualifications

Education:   

Bachelor’s degree in the life sciences or related will be considered with applicable job experience. (RN, PharmD, PA are preferred).

Required Experience: 

4 years of experience or the equivalent combination of education and experience.

Experience and skill requirement:

• Safety case processing experience is required.
• Oncology experience preferred.
• Physical Requirement: Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office environment.
• Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA regulations and guidelines, and other international regulatory requirements.
• Knowledge of MedDRA dictionary relevant to AE/SAE coding
• Experience with software-based drug safety systems (ARIS-G and/or ARGUS experience is required)
• Strong interpersonal and communication skills; proactive approach.
• Able to work both independently and in a team environment.
• Proficient in standard computer software (Word, Excel and Power Point)
• Some travel may be required (<10%)

About Replimune  Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com. 

We are an Equal Opportunity Employer. 

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