Medical Director Pharmacovigilance (Hybrid or Remote)
Location: Woburn, MA (Hybrid or Remote)
Posted Date: 03/06/2023
If you’re looking for a patient-focused, innovation-driven company that will inspire you, we invite you to apply. Join us as our Medical Director Pharmacovigilance.
Who we are…
Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 50 countries. We’re a fast-growing dynamic organization and we seek an experienced Medical Director Pharmacovigilance to help us with our growth.
At Sirtex, we’re transforming our industry through our leadership with interventional oncology and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. We offer stimulating careers and development, encourage innovation, and strive for excellence in everything we do. We will always foster a diverse and inclusive workplace, in which our global teams are united by an unwavering commitment to improve the quality and longevity of patients’ lives by providing innovative interventional oncology solutions.
Here, you will be a vital contributor to our inspiring and bold mission.
As a Medical Director Pharmacovigilance, you’ll be empowered to serve as the global patient safety expert for our drug-device combined products, accountable for the safety strategy and major safety deliverables. You will lead global safety and safety management and represent the cross-functional program team as a product safety profile and risk mitigation expert for both internal and external stakeholders. You will also manage cross-functional assessment of benefit-risk profile and communication of safety information.
How you will contribute…
- Conduct safety surveillance across the product lifecycle, reviewing clinical trial and post-marketing Medical Device Reports (MDR) or Individual Case Safety Reports (ICSR), including Adverse Events Reports (AE), Serious Adverse Event Report (SAE), and Product Complaints (PC). Identifies emerging safety issues.
- Analyzes aggregate safety data (CER, IDE/510K/PMA Annual Reports) from Clinical Study Reports (CSR), and Study Protocols. Provide medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents (e.g., protocols and amendments, International Classification of Functioning, Disability and Health-ICF, Investigator Brochures -IB, Investigational Medicinal Product Dossier -IMPD, clinical research reports, Health Hazard Evaluations, Signal Evaluation Reports, Investigational New Drug (IND), NDAs, Biologic License Application (BLA), and Clinical Trial Application (CTA) in collaboration with cross-functional colleagues.
- Provide Investigator communications including Dear Health Care Provider–DHCP letters and MEDWatch & MAUDE, and Systems Security Certified Practitioner-SSCP.
- Identifies concerns and communicates and manages emerging potential signals from safety data and communicates to internal/external stakeholders. Collaborates with Engineering and Quality personnel to manage analysis of clinical and post-marketing safety data, provides medical assessment, and instructs staff on appropriate query and follow-up activities.
- Collaborates with Clinical Development and Clinical Operations teams on safety of clinical studies to ensure accuracy, completeness, and quality of Clinical Trial MDRs. Provide patient safety input to the clinical development program and represent global safety on internal governance bodies for study protocols, statistical analysis plans and other clinical study-related documents as applicable.
- Leads and/or contributes to medical safety of clinical trials, including monitoring of clinical trial safety and laboratory data.
- Ensures timely medical review and assessment of MDRs or ICSRs, including seriousness, expectedness, safety narratives, adverse event coding, concomitant medication coding and causality statements. Raises any potential safety concerns/issues to manager and proposes resolutions.
- Contributes to Risk Management Plans (RMPs)/Risk Evaluation and Mitigation Strategy (REMS). Ensure communication of all safety information that may impact the benefit-risk profile.
- Performs aggregate review of post-marketing and clinical trial safety data in support of safety signal detection, validation, assessment, and development of risk mitigation strategies. Escalates safety concerns within the organization according to established safety governance policies.
- Performs responsibilities based on knowledge of applicable local/global regulatory regulations and guidance.
- Collaborate and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
- Ensure up-to-date representation of safety information in Company Core Data Sheet (including Reference Safety Information) and IB as well as other labeling documents.
- Demonstrate knowledge of both local and global health authority requirements.
- Train and mentor Pharmacovigilance Physicians and Specialists.
- Maintain professional knowledge and accreditation by active participation in continuing medical education activities and fosters a community of continual learning.
Your qualifications will be…
- M.D. or D.O. required. Board certification and licensure preferred.
- Direct clinical experience in patient care following post-graduate training and appropriate grounding and knowledge of general medicine.
- At least 10 years of experience in pharmaceutical (novel) or medical device industries within Drug Safety/Pharmacovigilance, with both investigational and marketed products. Oncology highly desired.
- Significant experience with aggregate reporting, safety surveillance, signal management and risk management.
- Knowledge and understanding of global PV and regulatory guidelines. Solid knowledge of EU and FDA as well as main global PV regulations.
- Knowledge of clinical trials, good clinical practices, and International Council for Harmonization-ICH guidelines preferred.
- True team player with strong leadership skills.
- Statistical and epidemiological knowledge a plus.
- Excellent problem solving, conflict resolution, and analytic thinking skills.
- Excels in communicating w/others effectively. Great presentation skills. English speaking is required.
- Ability to make effective decisions and manage several high-priority, fast-paced activities.
- Advanced/Intermediate-level computer skills.
- Sense of Humor-we take our patients and science very seriously, just not ourselves.
Our EEO statement…
Sirtex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.
Be part of an amazing team that is helping to save lives, every day.