Overview:
Be Seen and Heard at EyePoint
At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our:
- focus on science and innovation, we aim to offer a lifetime of clearer vision
- commitment to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases
- Delivery of innovative therapeutics to protect vision, specializing in sustained-release treatments for serious retinal diseases.
We See You.
- Your wellbeing
- Your professional worth
- Your future at EyePoint
EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected. 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.
The incumbent works cross-functionally with internal and external key stakeholders and external resources on pharmacovigilance-related matters.
This position will report into the VP, Pharmacovigilance. This role is remote.
Responsibilities:
Primary responsibilities include, but are not limited to, the following:
Individual responsibilities
- 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. Conduct cross-functional SRT working with safety physician on periodic and ad-hoc basis.
- 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:
Primary skills and knowledge required include, but are not limited to the following:
- 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.
Level of Education Required:
Bachelor’s or Master’s degree in science related area including BSN/RN, Pharmacy, PharmD degree
Number of Years of Experience in the Function and in the Industry:
- 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.
Envision Your Future
With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.
The collective power of our values influences everything we do, and everything we do for you.
Transformational Innovation We exist to change our patients’ lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. |
Unwavering Integrity We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. |
Compassionate Excellence We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. |
Inclusive Collaboration We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward. |
EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity.
The target salary range for this position is listed below.
#LI-Remote
Min:
USD $197,760.00/Yr.
Max:
USD $249,947.00/Yr.
