Associate Director Pharmacovigilance

Lantheus is headquartered in Bedford, Massachusetts with offices in Canada and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. In 2023, Lantheus had more than $1B in revenues, led by sales of imaging agents for cardiac ultrasound and for prostate cancer.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Summary of role

We are seeking an Associate Director to join our Global Pharmacovigilance (GPV) team, focusing on managing business partnerships and coordinating pharmacovigilance activities for developmental products. This role will also oversee pharmacovigilance migrations and transitions related to company or product acquisitions. Finally, the role will provide support to the Director, Pharmacovigilance for management of departmental activities. The ideal candidate may work independently and serve as the GPV liaison across various functions within Lantheus, as well as with external business partners, ensuring seamless collaboration and compliance with regulations.

Key Responsibilities/Essential Functions

Developmental Products:

• Lead interactions with Lantheus' Clinical Research team and Lantheus' pharmacovigilance vendor to ensure all safety reports received from all studies are processed in a consistent and a fully compliant manner.
• Provide direct technical /data management support to ensure information entered and retrieved from the safety database is consistent, accurate and complete in accordance with data requirements.
• Ensure the processing of safety reports is efficient and compliant with reporting requirements detailed in pharmacovigilance vendor safety management plans (SMP), applicable PV agreements, and applicable legislation.
• Support development and maintenance of a dashboard documenting current status of all ongoing studies and provide timely updates to the pharmacovigilance team.
• Provide guidance and support to study project teams for safety-related areas, including protocol development and study conduct.
• Assist as needed with the preparation and updates to Investigator Brochures (IB), IND Annual Reports, Development Safety Update Reports (DSURs), Protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), Company Core Data Sheets (CCDS), Risk Management Plans (RMP), Risk Evaluation and Mitigation Strategies (REMS) etc.
• Assist with the ongoing review (Tables, Figures, Listings [TFLs]) and Adverse Event (AE) data from ongoing studies to evaluate common AEs, laboratory abnormalities, and summarize the results in support of regulatory submission activities, signal detection and management activities, or in response to ad hoc safety inquiries from health authorities.
• Assist with response to safety-related queries from regulatory authorities or Ethics Committees, if needed.

Business Partner Engagement:

• Support the oversight and management of global business partner and vendor safety data exchange agreements (SDEAs), pharmacovigilance agreements and other contracts as applicable to ensure compliance with data exchange requirements.
• Communicates with business partners and vendors regarding processing and timely exchange of safety data as per SDEAs and vendor SMPs.
• Ensures that safety data, aggregate reports and other documents are distributed to business partners as required and assists with reconciliation activities.

Mergers and Acquisitions:

• Support the development of Lantheus Global Pharmacovigilance department to ensure adequate infrastructure is available for additional activities occurring as a result of product and/or company acquisitions.
• Support migration and transition activities from due diligence until close-out. Ensure all milestones pertinent to pharmacovigilance are met.
• Develop and execute required pharmacovigilance plans (summary of pharmacovigilance systems, project tracker, transition plan, data migration plan, updates to SMPs, etc).

Other Requirements:

• Provide support to the Director, Pharmacovigilance for general management of departmental activities, as requested.
• Works cross functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into Lantheus practices and procedures.
• Develop and maintain Global Pharmacovigilance related documents including Safety Management Plans, Standard Operating Procedures (SOPs) and Work Instructions.
• Oversee deviation and Corrective Action Preventive Action (CAPA) activities in relation to, but not limited to, late expedited report or aggregate report submissions, deviations from Lantheus procedures, business partner agreements, vendor SMPs, etc.
• Adhere to company policies and applicable regulations including reporting of adverse events to regulatory agencies.
• Other duties as assigned.

Basic Qualifications

• Bachelors/Advanced degree preferably in life science, nursing, pharmacy or other healthcare related profession (RN, PharmD, NP, PhD, MPH, etc.)
• 8+ years of direct pharmacovigilance work experience in the pharmaceutical industry
• Experience with an ICH E2B-compliant database is a must; experience with ARGUS is preferred
• Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines)
• Experience of processing and expedited submission of safety reports is highly preferred
• Knowledge of MedDRA and WHO Drug dictionaries
• Experience with overseeing and managing vendors
• Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting
• Experienced in partner engagement (development of SDEAs, compliance and quality management of SDEAs)
• Solid clinical knowledge and strong analytical ability to review, evaluate, interpret, and synthesize clinical and safety data
• Strong proficiency in verbal and written communication; great attention to detail, ability to meet project deadlines
• Ability to work independently, to manage work priorities, to lead projects, to build collaborative team relationships at all levels and remain flexible to the needs of the teams / projects. Must be able to work on multiple projects simultaneously
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
• Proficient in standard computer software (Word, Excel and Power point presentations)

Other Requirements

• The position requires the candidate to be on-site in Bedford, Massachusetts for business 3 days/week.

Core Values:

The ideal candidate will embody Lantheus core values:

• Let people be their best
• Respect one another and act as one
• Learn, adapt, and win
• Know someone's health is in our hands
• Own the solution and make it happen

Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.

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