2 to 4 years
This role is STARs-friendly: Skilled Through Alternative Routes.
34% STARs in role.
Job Description
The Global Risk Management & Safety Surveillance Scientist will play a key role in characterizing and communicating the evolving clinical and post‑marketing safety profiles of investigational and marketed products, with a primary focus on oncology. This role actively supports global pharmacovigilance activities by leading signal detection, contributing to aggregate safety reports, and collaborating closely with physicians, scientists, and cross‑functional stakeholders across regions. The position offers the opportunity to oversee a marketed product in Europe, contribute to regulatory submissions, and support health authority interactions in a highly collaborative, international safety organization.
Responsibilities
- Collaborate with Global Risk Management & Safety Surveillance (GRMSS) Physicians and Scientists to characterize the evolving clinical and post‑marketing safety profiles of investigational drugs and marketed products using aggregate data from internal databases, external partners, and the medical literature.
- Draft, review, and refine portions of periodic aggregate safety reports, including Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs/PAERs), Periodic Benefit‑Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).
- Perform signal detection activities for clinical and post‑marketing safety data, including signal detection, evaluation, and verification, using data from internal sources, external marketing partners, and contracted business entities.
- Document signal detection activities in a clear, structured manner and communicate concise and accurate summaries to internal and external stakeholders.
- Provide support to GRMSS Physicians in the periodic review of medical and scientific literature to identify new and important safety information related to assigned products.
- Serve as the primary safety surveillance scientist overseeing one of the marketed products in Europe, ensuring robust ongoing safety evaluation and timely reporting.
- Oversee and critically review the writing and editing of PSURs and other key aggregate safety documents for the assigned marketed product, ensuring scientific accuracy, regulatory compliance, and alignment with internal standards.
- Review DSURs and other safety reports for clinical trials associated with the assigned product, ensuring consistency across development and post‑marketing safety information.
- Attend and actively participate in product‑related meetings, including safety review meetings and cross‑functional discussions, providing expert input on safety data and risk management.
- Support responses to health authority requests related to the safety of the assigned product, including preparing or contributing to written reports, justifications, and follow‑up documentation.
- Contribute to the evaluation of safety events that may impact the product label and support the preparation of reports and documentation related to proposed label changes.
- Collaborate effectively with colleagues located in different regions, including team members in the United States and Switzerland, to ensure consistent and high‑quality safety surveillance activities.
- Two to four years of pharmacovigilance or drug safety experience, including hands‑on involvement in post‑marketing and/or clinical trial safety activities.
- Demonstrated experience analyzing individual case safety reports and aggregate safety data for the preparation of periodic safety reports such as PSURs, PADERs, and PBRERs.
- Proven experience in signal detection and signal evaluation, including the ability to interpret complex safety data and identify potential safety signals.
- Experience responding to queries from regulatory authorities related to safety data, aggregate reports, or risk management activities.
- Healthcare degree preferred, such as BSN, CRNP, Pharm.D., or a relevant scientific degree supported by significant industry experience in pharmacovigilance or drug safety.
- Working knowledge of clinical trial safety surveillance processes and requirements.
- Ability to write, review, and edit scientifically sound safety documents with strong attention to detail and regulatory expectations.
- Strong analytical skills with the ability to interpret large, complex safety datasets and derive clear, evidence‑based conclusions.
- Effective verbal and written communication skills for summarizing safety findings and presenting them to diverse stakeholders.
- Ability to collaborate in a cross‑functional, international team environment and manage interactions with internal and external partners.
- Experience working in oncology drug development or oncology pharmacovigilance.
- Background in a sponsor, contract research organization (CRO), or large pharmaceutical environment, with the ability to adapt to different organizational structures.
- Familiarity with the preparation and maintenance of Risk Management Plans (RMPs) and Development Safety Update Reports (DSURs).
- Comfort working with global teams across multiple time zones, including close collaboration with colleagues based in Switzerland.
- Ability to manage multiple safety deliverables and deadlines while maintaining high quality standards.
- Strong organizational skills and the ability to work independently while contributing effectively to team objectives.
The role sits within a global safety organization composed of a team of approximately twelve safety scientists distributed between the United States and Switzerland. You will collaborate closely with physicians, scientists, and cross‑functional partners in a matrixed, international environment, often coordinating across time zones to support a marketed product in Europe. The work is highly analytical and document‑focused, involving regular use of safety databases, clinical trial systems, and standard office productivity tools to review data, prepare aggregate safety reports, and support regulatory interactions. The environment emphasizes scientific rigor, regulatory compliance, and clear communication, with a strong culture of collaboration and knowledge sharing across regions and functions.
Job Type & Location
This is a Contract position based out of Wilmington, DE.
Pay and BenefitsThe pay range for this position is $55.00 - $55.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
This is a fully remote position.
Application DeadlineThis position is anticipated to close on Jun 26, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: 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.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
Posting ID: JP-006104734
