- Accountable for individual case safety reviews of clinical and post-marketed adverse events as part of their day to day scope of work
- Creation and editing of global aggregate reporting requirements in North America, Asia-Pac, Latam and EU (DSUR, PAER, PBRER/PSUR, EPV reports and Risk management plans (RMPs)
- Deep understanding of Literature reviews, signal management, risk management practices, and monitoring the safety profile of PharmaEssentia products in clinical development and post-approval assessing benefit-risk profile and ensuring compliance with all applicable US and Foreign legal and regulatory requirements
- Key contributor to the safety section in the development of protocols, investigator brochures, labeling/CCDS, ICF's, etc., regulatory documents such as NDA, IND, and BLA submissions
- Experience with SDEA and PVA's
- Oversee the implementation and maintenance of a global safety signal detection system that includes tracking, documentation of signal evaluation, outcome, and communication
- Collaborate closely with Preclinical, Clinical, Regulatory Affairs and Medical Affairs to ensure efficient and robust strategic integration of drug safety plans
- Closely supervise all major written deliverables (regulatory submissions, original articles, abstracts, commercial, etc.), and presentation materials that contain safety information
- Maintain a global benefit-risk strategy for each pre-market, marketed and future PharmaEssentia product that includes risk management and minimization
- Prepare safety information to support licensing partners, communicate with licensing partners and contract organizations on safety matters per agreements
- Develop SOPs for the development of related medical oversight needs within safety and develop/lead safety management team (SMT) meetings
- MD Required
- 10+ years of relevant emerging biotech/pharmaceutical industry experience within clinical and post-approval pharmacovigilance.
- Experience working with the a global safety database, medical coding (medDRA and WHO) and other data systems in clinical setting
- Experience in leading pre-launch, launch, and post-launch product safety
- Knowledge of the drug development process; strong understanding of technical, business, and regulatory issues.
- 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
- 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
- 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
- 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
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Safety Physician, Product Safety - Burlington, United States - PharmaEssentia U.S.A.
Description
Job Description
Job DescriptionPosition Overview:
The Safety Physician is responsible for supporting strategic medical leadership for all Product Safety & Risk Management (PSRM) global initiatives. The incumbent will be expected to provide medical oversight for all activities and safety reports/plans required at all stages of the product life cycle; clinical development through commercialization. This position requires cross-functional work and the ability to liaise between the PV team and other departments. This person is to be the medical safety SME for the product(s) and represent safety on key initiatives. This individual will perform as a hands-on team leader who is collaborative, a self-starter, and able to work in a global organization in a collaborative, fast-paced matrixed team.
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:
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:
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.
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