LEAD PHARMACOVIGILANCE PHYSICIAN – #2472
Our client company is a rapidly expanding global clinical stage biopharma company focusing on the discovery, development, and commercialization of innovative targeted Oncology therapies. The company has multiple assets in clinical development and a growing pipeline of innovative early-stage assets entering clinical trials globally, including multiple Phase I/II clinical trials in the US.
The Lead Pharmacovigilance Physician (may be at the VP level) will serve as the medical safety professional supporting medical safety strategy and overall safety profile for the assigned products throughout their lifecycle. This person should be familiar with regulatory requirements of referred countries, and effectively interface cross-functionally at all levels in the organization. He/she will support all major pre- and post-marketing safety deliverables including IND safety reporting, signal detection, benefit-risk evaluation, aggregate safety reports and risk management strategies/activities.
Note: This position is home-based with a flexible work schedule and limited travel requirements.
- Conducting medical review to Individual Case Safety Report (ICSR) from any source including clinical trials, literature, post marketing studies and post marketing spontaneous adverse event reports;
- Reviewing ICSR to ensure the events are accurately reported and correctly coded with MedDRA; Evaluate medical contents and case completeness, trigger medical queries as needed;
- Assessing the event expectedness and company causality, identify potential safety signals at single case level or aggregate level; Prepare, Review and approve Analysis of Similar Events and provide company comments and assessment with medical analysis for SUSAR/IND Safety Reports;
- Conducting regular or periodic aggregate review on safety information to monitor and identify new safety signals if available
- Determining the reportability of the cases according to related regulatory requirements, including China, US, Japan et al.
- Preparing and reviewing safety-related section(s) for clinical, regulatory, and scientific documents including protocols, informed consent forms, case report forms (CRFs), statistical analysis plan (SAP), clinical study reports, integrated safety summaries, et al.
- Developing and maintaining Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling.
- Conduct signal detection activities to ensure signal identification, evaluation, validation, for assigned products including individual and aggregate data analyses;
- Lead risk-benefit evaluations and contribute to preparation of Risk Management/Control Plans (RMPs/RCPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements.
- Contribute to the preparation of p aggregate safety reports including DSUR, PSURs/ PBRERs/PADERs for marketed products, and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products.
- Support inspection readiness activities, internal audits and external inspections.
- Keep abreast of new PV/safety regulations and guidance from the regulatory authorities.
Knowledge, Skills & Abilities
- Medical education is a mandatory, with a preference for Clinical research and/or fellowship training.
- Minimum 5 years Pharmacovigilance experience. Other clinical development relevant experience may be considered.
- Working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP), with a thorough understanding of case processing and other pharmacovigilance processes.
- Experience/exposure to working relationship on PV with the FDA and other regulatory authorities is mandatory.
- Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork.