Job Description
SK Life Science, Inc Senior Director, Pharmacovigilance Physician in Paramus, New Jersey Senior Director, Pharmacovigilance Physician
Job Locations: US-NJ-Paramus
ID: 2025-1870
Category: Regulatory Affairs
Type: Regular Full-Time
Overview: The Senior Director, Pharmacovigilance (PV) Physician will provide broad support of activities requiring medical safety input for assigned products, pre- and post-approval. They will support and/or lead periodic safety signaling reviews and meetings, as well as perform individual and aggregate case review. The Senior Director will also participate, in varying degrees, on clinical teams/programs and other intra and/or inter-departmental activities and initiatives.
Responsibilities Ensure PV Medical Safety activities are performed in compliance with all applicable regulations and SKLSI standards.
Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
Provide oversight for the safety aspects for clinical studies, including participation at DMC meetings, and development and maintenance of the company core safety information.
Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, informed consent forms, final study reports, IB/RSI and other documents as needed.
Provide timely and sound medical review of individual case safety reports from clinical trials or post-marketing sources as needed.
Lead the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices.
Assess safety signals and trends and proactively manage any potential safety issues.
Determine need for pharmacoepidemiology input and liaise with external pharmacoepidemiologist.
Lead development of Risk Management Plans, implementation and evaluation of their effectiveness.
Ensure safety issues are communicated to the appropriate stakeholders in a timely fashion.
Author analysis of similar events (AOSE) and individual case comments for ICSRs.
Accountable for medical evaluation/interpretation of aggregate safety data of assigned product(s) including signal detection and evaluation, regulatory safety reports (DSUR, PADER, PBRER/PSUR) and ad hoc safety assessments.
Maintain knowledge of global regulatory authority regulations including FDA and EMA.
Formulate response strategies for safety-related health authority and ethics committee requests.
Represent PV in communications with health authorities such as the FDA.
Participate in departmental development activities including SOP and Work Instructions development.
Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
Contribute to the training, leadership and continuing education for department staff.
Provide a contributory role in Partner/Affiliate agreements and interactions, as needed.
Other duties as assigned.
Qualifications MD degree or equivalent with clinical post-training resulting in eligibility for a US medical board certification.
MPH or pharmacoepidemiology expertise a plus.
A minimum of 12 years of relevant drug safety experience in the biotechnology/pharmaceutical industry, including a minimum of 8 years of safety leadership experience.
Neurology, psychiatry, or CNS-related disease experience also a plus.
Thorough understanding of U.S. pharmacovigilance regulations, GCP and International Conference on Harmonisation (ICH) guidelines.
Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA.
Extensive knowledge of all types of aggregate safety reports.
In-depth understanding of the drug development process.
Extensive experience in partnering with vendors to achieve results.
Exceptional written and verbal communication skills.
Ability to build and sustain trusted relationships both internally and externally.
Proficient computer skills, including Microsoft Word, PowerPoint and Excel.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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Job Tags
Full time,