Sunovion Pharmacovigilance & Risk Management Internship in Marlborough, Massachusetts
This summer internship will offer college and university students an amazing opportunity to gain hands on experience within the pharmaceutical industry. This program allows students to work closely with business leaders while obtaining industry insight. Interns will be tasked with both individual and group projects. The Sunovion Internship Program will offer additional workshops and seminars for your career and professional development. We are seeking talented individuals within multiple areas across the organization.
Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. The Company has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological, and respiratory conditions.
Specific Internship Description:
The Principal Scientist Intern will report to the Director PVRM Lead as part of a team that performs high quality and timely scientific and operational analysis of pharmacovigilance information. This intern will work closely with the Safety Systems & Information Management and Strategic Alliance, Compliance & Training groups as part of a matrix team to support the Therapeutic Area business unit by ensuring that pre- and post-marketed products are adequately supported from a safety standpoint.
With the PVRM Lead, and Sunovion Principal Scientist, the intern will learn to perform safety surveillance activities within a product(s) team that include:
Evaluation of data, identification of opportunities and risks, weighting alternatives and presenting analyses to Medical Director for review.
Organize planned and ad hoc safety review activities - Obtain data for signal assessment (e.g., Oracle AERS, FDA AERS data, literature search); generate/request listings, identify cases, prepare initial assessment for review and finalization by Medical Director, follow-up on meeting outcome (as needed), ensure the appropriate maintenance of relevant documentation
Quarterly AE Review of Clinical Trials - Perform first iteration of listings review, discuss issues with Medical Director
Lot Review - Prepare listing and table for Medical Director review and summary
Literature Surveillance - Perform review of literature with appropriate documentation; identify case reports as well as new safety information and alert Medical Directors, as appropriate Risk Management/Post-Approval Commitments
Under supervision of the Medical Director, PVRM Lead and/or Principal Scientist, contribute to creation, annual review and update of RMPs as needed.
Follows up on safety related post-approval regulatory commitments or assigned products.
Under supervision of the Medical Director, contribute to creation, annual review and update of RMPs as needed.
Follows up on safety related post-approval regulatory commitments for assigned products.
Aggregate report drafting and data collection (i.e. PSUR, PBRER)
Support Clinical Trials
Oversee and perform case processing activities working with CTSA to ensure consistency, as needed
Investigator Brochure (IB): Contribute to creation, review and updates of IB
Aggregate Reports for investigational products such as DSURs, ASRs, IND Annual - collect, collate, format and draft PVRM data contribution
IND Safety reports - analysis of similar events - Collect, collate, format and draft data contribution and perform first review
Database Lock - Perform reconciliation and signoff
The intern for PV Safety Science will learn the basic principles of pharmacovigilance, activities associated with this discipline (e.g., signal detection report and analysis, signal identification, prioritization, signal management, aggregate reporting, periodic reporting compilation and analysis, etc.), and safety governance.
Enrolled in undergraduate degree program in Health Care discipline (RN, BSN, RPh, PharmD, Nurse Practitioner, Public Health, or Physician Assistant, etc.)
Must have completed their sophomore year of study
Authorization to work in the U.S. without requiring sponsorship
Abide by corporate policies, work in professional environment and meet deadlines
Experience using Microsoft Office (Excel, PowerPoint, Word.)
Strong communication skills and passion for continued development
- Covid-19 Vaccinations are required
Position will begin on Monday June 5, 2023
Position is located remotely in the US
Position is full-time Monday through Friday – up to 40 hours per week
Candidates should be available to commit to 10 weeks
Health and Safety: To maintain the health and safety of our employees, patients, and affiliates, as well as comply with the vaccination requirements of our partners, employees are required to be vaccinated against COVID -19. Candidates hired must provide proof of vaccination against COVID-19 within 5 days post hire as a condition of employment. In accordance with Equal Employment Opportunity laws, exemptions for religious and medical reasons will be considered.
Confidential Data : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
For more information about EEO and the Law, please visit the following pages:
Equal Employment Opportunity is THE LAW (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)
EEO is the Law Poster Supplement
Pay Transparency (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
Lead the way to a healthier world by putting patients at the center of everything we do
We are focused on developing innovative therapies and transforming the lives of people with serious medical conditions. We are creating innovative psychiatric, neurological and respiratory therapies that help transform people's lives, while at the same time we are playing an increasingly active role in the future of global health.
Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer. Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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