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Role Description

The Director, Pharmacovigilance Sciences will work with the Pharmacovigilance (PV) physicians on all aspects of medical surveillance and risk management activities for investigational and marketed products. This position will report into the VP, Pharmacovigilance. This role is remote.

• Ensure oversight and assume overall responsibility/accountability for assigned product or therapeutic area pharmacovigilance activities.
• Overall project management responsibility for compiling pharmacovigilance aggregate reports (e.g., DSUR, PBRER, topic reports) and ensure effective planning such that stakeholder input is requested/received for applicable sections of the report meeting regulatory timelines.
• Contribute to relevant sections collaborating with safety physician.
• Provide guidance to other functions to contribute relevant section and address questions.
• Overall project management responsibility for compiling safety information for Clinical Overviews, responses to regulatory questions, post-marketing safety assessment, Risk Management Plans, labeling justifications, CCSI development, IB update, label update as well as written summaries of clinical safety of common technical document.
• Assume lead role in review and approval process for all pharmacovigilance reports working in conjunction with safety physician and external pharmacovigilance vendor.
• Collaborate with the safety physician to ensure all information is available to allow for informed medical review and benefit-risk assessment of assigned product/s.
• Conduct safety surveillance and signal detection activities for assigned product or therapeutic area.
• Responsible for ensuring efficient plan for routine and ad-hoc Safety Review Team (SRT) meetings and that stakeholder provide input from their respective areas of responsibility.
• Ensure that regulatory and RMP commitments are efficiently tracked and presented as part of the SRT process.
• Liaise with SRT chair to facilitate communication and support for decisions resulting from the SRT (e.g., update of RMPs, labeling, regulatory notifications).
• Effectively collaborate with stakeholders outside of PV.
• Represent PV department in cross-functional clinical programs and registration activities and provide support to clinical developmental programs.
• Collaborate with medical monitor(s), safety physician and Regulatory Affairs to process, review, submit, track and monitor expedited safety reports to appropriate domestic and international regulatory authorities.
• Provide support to Drug Safety Monitoring Board.
• Provide oversight and contribute to draft, review and track of safety data exchange agreements and pharmacovigilance agreements with Alliance partners.
• Provide guidance, training, and oversight to pharmacovigilance vendor supporting pharmacovigilance activities for investigational and marketed products.
• Maintain a thorough understanding of clinical protocol(s) and the scope of work for assigned projects.
• Develop, implement and support policies, standard operating procedures (SOPs), tools, etc., pertaining to pharmacovigilance activities.
• Support PV audits and inspections. Participate in audit preparedness activities and serve as subject matter expert during regulatory inspections in collaboration with team members.

Qualifications

• Strong knowledge and track record in pharmacovigilance sciences including signal detection, safety reviews, literature searches, aggregate safety reports, and clinical documents such as IB, protocol, & ICF.
• Experience with pharmacovigilance of both investigational and marketed drugs.
• Experience and knowledge of safety databases; strong knowledge of medical terminology and understanding of MedDRA search strategy.
• Advanced knowledge of FDA regulations, ICH guidelines relating to pharmacovigilance, and Ex-US PV regulations experience.
• Excellent oral and written communication skills.
• Ability to build cross functional relationships.
• Proficiency with Word, PowerPoint. Basic Excel Skills.
• Up to 10% travel may be required.
• Bachelor’s or Master’s degree in science related area including BSN/RN, Pharmacy, PharmD degree.
• Experience in ophthalmic products is highly desirable.
• Minimum of 8 years progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, at least 3 of which were spent in a leadership role within pharmacovigilance.
• Experience in signal detection, safety surveillance, risk mitigation and risk management a plus.
• Demonstrated hands-on experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality.
• Ability to work independently and collaboratively, as required, in a fast-paced matrixed team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Benefits

• Robust total rewards in a science-based entrepreneurial culture.
• Empowerment of curiosity and innovation.
• Space for every voice and perspective to be heard in on-site and remote environments.

Company Description

EyePoint is committed to preventing blindness by developing and commercializing innovative therapeutics. We value diversity and inclusion among our colleagues and seek to recruit, develop, and retain the most talented people from a diverse candidate pool.