Associate Director, North America Pharmacovigilance

Recordati Rare Diseases, Inc. (RRD), a part of Recordati Group, develops high-impact therapies for devastating rare diseases. At RRD, we focus on the few – those affected by rare diseases. They are our top priority and at the core of everything we do.

RRD is a biopharmaceutical company committed to providing often overlooked orphan therapies to the underserved rare disease communities of the United States. RRD's mission is to reduce the impact of extremely rare and devastating diseases by providing urgently needed therapies. We work side-by-side with rare disease communities to increase awareness, improve diagnosis and enhance availability of treatments for people with rare diseases. Recordati Rare Diseases operates three business units including our endocrinology, metabolic and oncology franchises. RRD is committed to attracting, developing, and retaining the top talent in the pharmaceutical industry. We provide our employees with a dynamic work environment and the opportunity to grow professionally while making a difference in our patients’ lives.

Reporting Structure

Reports To: Senior Director, Medical Information & Operations with dotted line to Head of Global PV

Direct Report(s): None

Areas Managed: North America Pharmacovigilance

The Associate Director of North America Pharmacovigilance (ADNAPV) is responsible for the leading the RRD’s North American pharmacovigilance (PV) function in conjunction with RRD’s Global Pharmacovigilance (GPV) for all registered products. The ADNAPV is responsible for providing PV leadership within RRD NA and with GPV. RRD’s NA PV function works in concert with RRD’s GPV function to ensure procedures and processes are in compliance with NA Regulatory Authorities and have proper oversight on activities performed by Global functions. RRD NA works with a range of third parties/partners, some of whom provide PV responsibilities. The ADNAPV is responsible for ensuring that partners with PV responsibilities are correctly contracted, trained to execute their PV responsibilities, monitored and in compliance with their PV obligations on an ongoing basis. As the primary PV resource in NA, the ADNAPV is responsible for working with regulatory authorities and GPV to ensure that RRD’s regulatory requirements are met as well as serve as the primary point of contact for questions, requests, and audits. The ADNAPV also serves as the subject matter expert on PV matters with RRD NA, providing guidance on PV-related issues to internal stakeholders. There is an operation aspect to this role which includes conducting phone follow for missing adverse event information, performing monthly reconciliation with partners, reviewing product complaints and medical information requests for potentially misses adverse events, etc.

Essential Duties and Responsibilities

Local National Contact Person for Pharmacovigilance (NCPP)

• Responsible to conduct PV activities for the products commercialized in the NA territory (Global PV is responsible for some local activities (e.g., case processing, signal detection, aggregate reports, worldwide literature searches, etc.)).
• Responsible to create and maintain a proper safety data collection system in NA.
• Responsible for ensuring the performance of local literature searches in NA.
• Coordinate with NA team the data collection for aggregate reports (PADER, PBRER) or other documents (PV Master File).
• Review all aggregate reports, PADER, local appendix for PBRER before submission.
• Support regulatory authority PV inspections in the NA territory.
• Ensure proper execution of vendor provided PV activities in Canada (i.e., Canada Vigilance Adverse Reactions Online Database monitoring, literature, submissions).
• Maintain local procedures describing NA PV activities.

NA Liaison to RRD Global PV

• Serves as the NA representative to GPV, supporting the development, refinement, and rollout of GPV policies, procedures, and systems.
• Represents the unique needs of NA in GPV discussions, ensuring that NA’s needs are understood and factored into GPV decision making.
• Ensures that all NA employees are trained on PV Reporting requirements.
• Provides guidance to RRD GPV for conformance with NA regulatory authority requirements.
• Follows up on missing information from an ICSR at the request of GPV.
• Notifies GPV of requests from CAs in NA and collaborates with GPV on responses, as needed as well as ensuring responses are submitted in a timely manner.

PV Partner Support and Management

• Serves as a resource during partner negotiations to ensure that partner PV responsibilities are understood and factored into discussions.
• Responsible for the development, maintenance, and compliant execution of Safety Data Exchange Agreements (SDEAs) with NA partners and distributors.
• Oversee the PV activities conducted under per the SDEAs including supporting Individual Case Safety Report (ICSR) reconciliations in conjunction with GPV.
• Conduct reviews of audit reports of partner safety activities on a timely basis and monitor CAPA execution with QA.

PV Subject Matter Expert and Function Lead

• Builds a deep understanding of the PV processes and challenges associated with RRD NA’s products and can explain those challenges to non-PV RRD team members.
• Serves as a resource for RRD team members in Medical Affairs, Quality Assurance, and Commercial functions that may have PV questions.
• Communicate PV metrics for NA for monthly reporting and PV Dashboard.
• Represents PV function in senior leadership meetings.
• Provide budget oversight

Education and Experience

• PharmD or RN degree preferred. Master’s or Bachelor’s degree in the life sciences or related will be considered with applicable job experience.
• At least 5 years of experience in PV with a pharmaceutical company
• At least 2 years of experience serving as a manager in the PV function
• Experience working with outsourced and / or partner execution of PV functions
• Experience working in a regional PV function in support of a Global PV function preferred
• Expert knowledge of relevant FDA and Health Canada PV regulations and guidelines
• Demonstrated technical, administrative, and project management capabilities
• Independently motivated, detail oriented with strong problem-solving ability
• Excellent organizational skills and demonstrated ability to effectively balance competing priorities
• Strong written and verbal communication skills with the ability to collaborate cross-functionally
• Start-up or small company experience strongly preferred

Knowledge and Skills

• Ability to build an excellent partnership with a Global function located in a different region
• Ability to manage partner execution of activities, building strong relationships while simultaneously holding the partner to high standards
• Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details
• Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
• Fluent in English (oral and written)
• Capacity to manage multiple projects
• Initiatives and self-motivation abilities
• Flexible and adaptable
• Well organized
• Positive thinking and enthusiasm
• Able to work in a small–mid size company
• Excellent computer skills. Strong proficiency in Microsoft programs: Excel, Word, PowerPoint
• Demonstrated ability to manage multiple competing priorities

Work Environment

This job operates in a professional office environment 2-3 days/week and remotely the remaining days. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Based upon job requirements, employee may be required at times to attend meetings including travel out of state over weekends and nights. Employee must be able to freely operate and travel by car and train/plane modes of transportation. Employee is required to have a valid driver’s license and means of transportation.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be able to fly via commercial air carrier.

This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear. Occasionally is required to lift and/or move light to moderate weight up to 25 lbs.

Location/Travel

• The location for this position is the New Jersey office
• This position requires minimal (less than 10%) domestic travel
• This position requires minimal (less than 10%) international travel

FLSA Classification

• This position is considered Exempt

EEO Statement

It is the policy of Recordati Rare Diseases to provide equal employment opportunity (EEO) to all persons regardless of race, color, religion, sex, sexual orientation, gender identity, or national origin. Further, Recordati Rare Diseases will not discriminate on the basis of any characteristic protected by federal, state, or local law. Recordati Rare Diseases will provide reasonable accommodations for qualified individuals with disabilities.

Disclaimer

This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required.