In this role, the clinician leads global drug safety and pharmacovigilance activities for assigned oncology products across clinical development and post-marketing. Day-to-day work centers on reviewing adverse events, evaluating benefit-risk, managing safety signals, and preparing safety documentation for regulatory and internal use. The position also involves cross-functional collaboration with clinical, regulatory, and external stakeholders, along with education, training, and mentoring around pharmacovigilance practices.
Key Responsibilities
- Lead pre- and post-marketing safety activities, including signal detection, benefit-risk evaluation, and risk management.
- Review adverse events, aggregate safety data, and scientific literature to support ongoing safety assessment.
- Prepare safety reports, benefit/risk sections, clinical overviews, and other regulatory submission documents.
- Provide input on trial protocols, amendments, clinical trial reports, eCRFs/CRFs, and TMFs from a safety perspective.
- Manage safety issues, propose risk mitigation actions, and communicate product risk updates to stakeholders.
- Support and oversee internal forums such as safety committees and external forums such as data monitoring committees.
- Guide, train, and mentor colleagues, CROs, and investigators on PV principles and safety processes.
- Collaborate with regulatory authorities, internal project teams, and external experts on safety strategy and inspections.
Required
- MD degree.
- At least 12 years of experience in drug safety/pharmacovigilance across clinical development and post-marketing.
- Experience with BLA and/or NDA submissions.
- Experience with PV audits and active participation in regulatory authority inspections.
- Experience working with FDA and other regulatory authorities.
- Experience with global PV regulations, MedDRA and WHODrug coding, and adverse event case processing and medical review.
Preferred
- Experience in oncology drug safety/pharmacovigilance.
- Experience using safety databases such as ARISg or ARGUS.
- Experience with electronic data capture systems.
- Experience guiding and mentoring team members.
Benefits & Perks
- Competitive salary range is provided for U.S.-based candidates.
- May be eligible for discretionary bonuses and long-term incentives.
- 401(k) plan with 100% match on the first 6% of contributions for eligible U.S. employees.
- Medical, dental, and vision insurance options.
- Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave.
- Backup care, family support programs, financial wellness tools, and emotional well-being support.
- Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account.