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Senior Manager, Global Drug Safety Operations
2 months ago
We are seeking a highly experienced Senior Manager to lead our Global Drug Safety Operations team. As a key member of our Pharmacovigilance team, you will be responsible for ensuring the timely and accurate collection, processing, and reporting of safety information from various sources.
Key Responsibilities- Oversee the successful and timely case intake of safety reports and case processing, ensuring compliance with regulatory requirements.
- Perform ongoing and real-time quality control review of safety case data entry in the safety database, adhering to data entry conventions and MedDRA/WHO DD coding conventions.
- Provide guidance on safety operations, including case processing, regulatory submissions, data entry, and safety queries, based on company conventions, ICH, and regulatory guidance.
- Develop or update Standard Operating Procedures, Working Instructions, and training materials around safety case processing and operations.
- Oversee and manage SAE Reconciliation activities, including review and approval of the reconciliation plan and generation of SAE reconciliation listings.
- Effectively manage safety case workload to ensure compliance with regulatory submissions and internal timelines.
- Investigate deviations and monitor Corrective Actions/Preventive Actions (CAPAs) relating to non-compliance issues and findings, assessing the effectiveness of CAPAs.
- Oversee open and answered safety queries in the EDC and ensure timely resolution of safety queries.
- Review and provide input on Safety Operational Management Plan on behalf of Safety Operations.
- Perform User Acceptance Test (UAT) on Safety Related Forms in EDC, ensuring correct dynamics and edit checks.
- Provide comments on the e-Safety Reporting Form Specifications document and perform UAT.
- Generate aggregate and ad-hoc reports for responsible products.
- Oversee other activities related to safety operations, including ICSR submission or distribution to ECs/IRBs/Investigators/Business Partners.
- Other activities, as needed or as requested by supervisor.
- Drug Safety professional with minimum 5 years of experience within drug safety and PV, inclusive of case quality control and regulatory submissions of ICSRs worldwide.
- Good knowledge of ICH E2B(R2) and (R3) specifications and entry guidance.
- Ability to interpret health and medical records, such as adverse event reporting forms, discharge summaries, etc.
- Good knowledge of pharmacovigilance reporting rules and timelines.
- Experience with clinical and post-marketing case processing, including MedDRA and WHO DD coding and narrative writing.
- Experience with safety database; Argus is a plus but not mandatory.
- Experience with EDC for clinical trial data collection.
- Analytic and strategic thinking.
- Excellent in detailed-oriented tasks.
We are looking for a passionate and dedicated individual who is committed to our purpose of transforming the lives of patients through innovative cancer treatment. You will bring rigor and excellence to all that you do, and be a fierce believer in our rooted-in-science approach to problem-solving.
You will be a generous collaborator who can work in teams with diverse backgrounds, and be determined to do and be your best, taking pride in enabling the best work of others on the team.
You will not be afraid to grapple with the unknown and be innovative, and have experience working in a fast-growing, dynamic company (or a strong desire to).
You will work hard and not be afraid to have a little fun while you do so.
