Scientist Associate Director PV Sciences, Global Medical Safety Oncology 6 Months

job summary:

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!

location: Cambridge, Massachusetts
job type: Contract
salary: $143.33 - 196.66 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

Principal responsibilities include:

- Supports the Global Safety Lead (GSL) for assigned oncology pharmaceutical / biological / drug-device combined products.

- Responsible for safety surveillance, signal detection and risk management activities.

- Supports cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.

- Provides pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products.

- Represent pharmacovigilance, both regionally and globally, as an authoritative and knowledgeable member of Global Program Teams (GPTs) and sub-teams, commensurate with position's seniority/experience.

- Coordinates all aspects of signal detection and safety surveillance and review activities, in collaboration with the GSL, for assigned product(s).

ACCOUNTABILITIES :

- Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing and scientific literature.

- Facilitate ongoing safety surveillance for assigned products, assisting with or leading data collection and assessment for the GPSE Safety Team (GST) and Safety Management Team (SMT).

- Coordinate and perform signal identification, evaluation and management activities for assigned products, ensuring communication of all safety information that may impact the benefit-risk profile of assigned products to senior management.

- Assist with or lead authoring of safety evaluations, defining scope and methodology and providing background information for aggregate safety reports, conducting preliminary safety analyses, and preparing ad hoc reports including Health Hazard Evaluations, Signal Evaluation Reports, and Health Authority responses.

- Partner with cross-functional colleagues of the SMT and contribute to safety-related deliverables associated with new drug applications, benefit-risk assessments and activities related to risk minimization including RMPs.

- Liaise with colleagues in relevant functional areas within and outside of PSPV to gather and provide input for appropriate sections of critical documents (e.g., protocols and amendments, ICFs, IBs, core data sheets, IMPDs, CSRs, INDs, NDAs, BLAs, and CTAs).

- Liaise with other relevant functional areas both within and outside of global PV to best ensure the most efficient and timely attainment of compliant and patient focused safety data.

- Represent PSPV in cross-functional teams or committees and external environments at a global and regional level as required, with the advanced communication skills this requires.

- Assist with or lead the preparation and presentation of identified and potential patient safety risks and SMT recommendations on safety issues to cross-functional decision-making bodies such as the company Safety Board. Where acting as the GSL can expect to lead presentations to Safety Board, with the detailed preparatory work this implies and, where ad hoc issues arise, manage the short timelines that can ensue.

- Build and maintain in-depth knowledge and understanding of designated products/studies, and close knowledge of protocols to effectively respond to safety issues.

- Ensure up-to-date representation of safety information in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents.

- Demonstrate outstanding knowledge of local and global health authority requirements.

- Support PSPV in the maintenance of a highly effective global safety organization in full compliance to worldwide regulations.

- Train and mentor newly hired peers and incumbent PV Scientists.

- Maintain professional knowledge and accreditation by active participation in continuing medical education activities, and foster a community of continual learning.

qualifications:

• Bachelor of Science or Health Care Professional degree (e.g., RN, BSN, NP, PA, RPh) or equivalent qualification; advanced degree in scientific or medical field preferred.
• Minimum 10 years of relevant biotech/pharmaceutical experience.
• Excellent working understanding of safety database configuration and adverse event coding to direct advanced searches.
• In-depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety data analysis and benefit-risk assessment, and understanding of drug development.

skills: Pharmacovigilance, Drug Safety, Individual Case Safety Report (ICSR), Risk Management Plan (RMP), Safety Data Analysis, Informed Consent Form (ICF), Investigational Medicinal Product Dossier (IMPD)


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.