The Role: Title: Safety Physician
Work location: 35 Corporate Drive Suite 325, Burlington MA 01803 (Hybrid or Remote) Position Overview:
The Safety Physician is responsible for providing strategic and operational leadership for all Drug Safety (DS) and Benefit Risk Management (BRM) functions within Pharmacovigilance (PV). The incumbent provides leadership and medical oversight for all PV processes and activities required at all stages of the product life cycle (clinical development through commercialization). The Safety Physician is accountable for adherence to relevant regulatory requirements and company SOPs as appropriate. This position requires cross-functional work and the ability to liaise between the PV team and other departments, external service providers and contract manufacturers. The position requires the ability to work independently and collaboratively, as required, in a fast-paced, matrixed team environment consisting of internal and external team members. The successful candidate must thrive working in an innovative environment while remaining flexible, proactive, resourceful, and efficient. They must excel in a multidisciplinary environment as an integral leader and can analyze complex issues to develop relevant and realistic plans, programs, and recommendations. The Company:
It's not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You'll find that rare opportunity at PharmaEssentia. Join us, and let's transform lives, together.
PharmaEssentia Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one approved product and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking.
Founded in 2003 PharmaEssentia Corporation is now listed on the Taiwan Stock Exchange (TWSE: 6446) and traded in the European markets. PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China and Korea, along with a world-class biologics production facility in Taichung, Taiwan. Key Responsibilities: As the PV leader, provide a strong, clear voice for the PV function including development of a global PV management system Provide strategic consultation and guidance on all decisions that have significant drug safety implications Establish, maintain, direct and communicate a global benefit-risk strategy for each pre-market, marketed and future PharmaEssentia product that includes risk management and minimization Establish metrics to monitor the PV system and ensure maintenance of internal and external regulatory compliance to the highest standards Oversee the implementation and maintenance of a global drug safety database capable of expedited and periodic reporting of safety data in accordance with current global regulatory requirements Oversee the implementation and maintenance of a global safety signal detection system that includes tracking of signal evaluation, outcome and communication Provide PV contributions in efforts to secure regulatory approvals Be accountable for the acquisition, processing, storage, retrieval and distribution of information concerning SAEs in clinical trials Collaborate closely with Research, Preclinical, Clinical, Regulatory Affairs and Medical Affairs to ensure tight strategic integration of drug safety plans Closely supervise all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials that contain drug safety information Prepare safety information to support licensing partners and contract research organizations, review safety documents prepared by licensing partners and contract organization, and communicate with licensing partners and contract organizations on safety matters per agreements Qualifications: 10+ years of relevant bio/pharmaceutical industry experience. Medical degree is required. Experience in leading pre-launch, launch, and post-launch product safety activities for a new, first-in-class, or otherwise innovative product is a plus Knowledge of the drug development process; strong understanding of technical, business, and regulatory issues. Experience in clinical development is a plus Be a diplomatic professional, integrating easily with the company and leadership, with the foresight and savvy to contribute to the corporate goal of becoming a leader in bringing innovative medicines to patients Highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company Able to command respect from peers and subordinates alike, capable of highly independent work as well as being a team player and role model. Key ability to interface with R&D and Commercial organizations Excellent verbal and written skills, allowing for an open and effective dialogue throughout the Company Keen attention to detail and quality Ability to work independently as well as part of a team environment Proven ability to manage multiple projects, identify and resolve issues Ability to influence without authority, lead change and manage resistance to change Must be able to solicit information, persuade others and shape outcomes Must have the passion and ability to forge and nurture key partnerships and collaborations with the external scientific community, including academia, governmental organizations, nonprofit organizations and CROs Benefits of working with our team:
PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits: Comprehensive medical coverage: 80% employer paid Dental coverage: 90% employer paid Vision coverage: 100% employer paid Generous paid time-off 401(k) retirement plan with competitive company match Medical & Dependent Care Flexible Spending Account Up to $150 monthly cell phone reimbursement Employee Assistance Program EEO Statement:
At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.
PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies. At PharmaEssentia, our goal is to treat as many people with cancer as possible. That means challenging the status quo with better science that leads to better lives. By joining our team, you will not only expand your own possibilities, but you will contribute to expanding options for people with cancer.
