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Manager of Pharmacovigilance Operations
2 months ago
Beacon Hill Staffing Group - Pharmacovigilance Operations Lead
The contract Pharmacovigilance Operations Lead will oversee ICSR case processing and provide medical review supervision in partnership with PV vendors, Safety leads, Safety Scientists, and Medical monitors to ensure efficient and high-quality ICSR case management from ongoing clinical studies.
Working closely with the Senior Director of PV Operations, this role will support the administration of the Safety database through a PV vendor, including oversight of ICSR medical reviews, quality assurance checks, and documentation of findings and trends, as well as managing the DSPV safety mailbox with a focus on global regulatory compliance.
This position requires effective cross-functional collaboration at all organizational levels, including but not limited to the Pharmacovigilance team, Clinical Operations, Regulatory Affairs, Quality Assurance, and various teams involved in clinical development initiatives. Additionally, the individual will engage with external stakeholders, investigators, vendors, and Regulatory Authorities.
Key Responsibilities:
- Develop and implement medical review strategies for ICSRs across clinical trial platforms in conjunction with PV operations, Safety surveillance teams, and CROs.
- Provide oversight for ICSR medical reviews in collaboration with CRO medical reviewers and internal Safety and medical teams as necessary.
- Manage the safety database through the PV vendor.
- Collaborate with the PV operations team and PV vendor to ensure timely and high-quality ICSR submissions from intake to reporting.
- Represent DSPV in various cross-functional teams, such as Clinical Study Teams and Medical Monitoring Meetings.
- Ensure that safety reports are triaged, scheduled, processed, and reported in accordance with global standards and internal SOPs.
- Facilitate daily interactions with internal vendors under the guidance of DSPV Operations management related to case processing.
- Work with PV vendors, clinical study vendors, and regulatory operations to ensure compliance and quality in safety reporting (e.g., KPI).
- Communicate with partner companies, vendors, and internal teams regarding the processing and timely exchange of safety reports under the direction of the DSPV Operations Director.
- Support the development and execution of Safety Management Plans for study-specific workflows between the organization and CROs.
- Assist in the creation, review, and maintenance of up-to-date safety case processing SOPs and forms.
- Represent DSPV Operations in study management teams for assigned products as needed.
- Assist with the reconciliation of safety data with data management and business partners as applicable.
About You:
- Experienced safety professional (RN, PharmD) with a solid clinical background from direct patient care.
- A minimum of 7 years of experience in drug safety and pharmacovigilance, particularly in medical review and ICSR case processing within novel clinical development programs.
- Comprehensive knowledge and practical experience with good pharmacovigilance practices and international regulatory requirements, including EMA/FDA/ICH guidelines for ICSR case processing, encompassing intake, medical review, and regulatory submissions.
- Familiarity with the MedDRA dictionary and strong skills in case processing and narrative writing.
- Proficiency with software-based drug safety systems (e.g., ARGUS, ARISg, or equivalent) and strong computer skills (MS Office).
- Previous experience with gene therapy products or biologics, along with direct patient care experience as a clinician, will be advantageous.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.#J-18808-Ljbffr
