Pharmacovigilance Operations (Senior Director - Executive Director) - Merus
Cambridge, MA 02142
About the Job
Description
Company Overview
At Merus, we are advancing leading-edge, targeted treatments using our pioneering multispecific antibody generating technologies, Multiclonics®, to address the unmet needs of patients with various types of cancer. Working at Merus gives you the opportunity to contribute to our mission of closing in on cancer. We care deeply about improving patients’ lives. This is why we are committed to getting this right, with a global and diverse team of highly qualified professionals. We have bold aspirations because the need is great, and the patients are waiting. Join us and make an impact.
Key Responsibilities
Your role:
Merus is seeking a Sr/Exec Director, Pharmacovigilance (PV) Operations who will be accountable for overall PV operations for Merus, which includes all aspects of adverse event collection, processing and reporting from all sources, safety systems, alliance and vendor management, development and training activities, for the entire portfolio in clinical development and post approval. The Sr/Exec Director leads the PV operations team and plays a critical leadership role in internal and external collaboration to ensure PV operational excellence and regulatory compliance.
Merus is seeking a Sr/Exec Director, Pharmacovigilance (PV) Operations who will be accountable for overall PV operations for Merus, which includes all aspects of adverse event collection, processing and reporting from all sources, safety systems, alliance and vendor management, development and training activities, for the entire portfolio in clinical development and post approval. The Sr/Exec Director leads the PV operations team and plays a critical leadership role in internal and external collaboration to ensure PV operational excellence and regulatory compliance.
The position reports to the VP of Pharmacovigilance/Head of Safety and is remote based but will be affiliated with the Cambridge, MA office location and will be expected to travel to the office as needed for meetings and other business needs.
In this role you will:
- Lead, manage, and develop PV operations team
- Work with the drug safety leadership team, to develop the strategy and implementation of PV system, processes and vendor deployment
- Manage the global PV processes to ensure compliance with all applicable laws and regulations
- Responsible for all PV operational aspects for entire portfolio in clinical development and post approval
- Ensure that all safety reports received from any source are processed and reported according to ICH guidelines, regulatory requirements, and company SOPs and procedures
- Mange PV team that oversees execution of ICSR collection, processing, reconciliation and reporting, including associated quality and training activities to ensure regulatory timelines and global standards are met
- Facilitate and ensure communication with internal functions and external vendors and license partners involved with receiving, investigating, or reporting AEs
- Oversee PV vendors performing case management and study support activities; oversees the development of maintaining of study-specific safety management plans
- Lead the development of PV agreement with license partners and/or other parties as required
- Operationally support signal detection, aggregate report preparation and safety labeling updates
- Support the preparation and review of the safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, IND/NDA/BLA/MAA and other regulatory submissions
- Oversee PV audits, inspections, CAPA activities as required
- Prepare and maintain drug safety departmental policies that address the processing, analysis and reporting of safety information to ensure proactive surveillance of compounds across life cycle.
- Ensure awareness and training of appropriate Company personnel and external groups of PV and Drug Safety principles, policies and SOP
- Oversee PV operational personnel that contributes to DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, submission documents and safety label
- Provide PV guidance and support for interdepartmental and/or corporate initiatives
- Participate in the development and management of departmental budget planning, negotiation, and implementation including long-range department operational planning.
Skills, Knowledge and Expertise
Your profile:
We are looking for a candidate with:
- Bachelor’s Degree including a Health care degree (RN, Pharm D) or PhD in biomedical or pharmaceutical sciences and extensive drug safety experience in oncology highly desirable
- Minimum 15 years of PV operations experience within the biotechnology or pharmaceutical industry is required, including 8 years in management position with direct reports
- Previous demonstrated success in leading PV operations function in the industry
- High EQ with demonstrated skills and experience fostering a positive culture within a PV organization
- Expert knowledge of global PV requirements, e.g. US Code of Federal (CFR) regulations, European Union (EU) Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines
- Experience and extensive working knowledge of MedDRA and proprietary safety databases, PV processes for individual case medical review, signal detection and evaluation, aggregate data assembly, review and report, as well as clinical study safety management
- Experience managing business process outsourcing vendors and relationships
- Experience with the compilation, writing and reviewing of safety documents such as DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, submission documents and safety labels
- Experience with audits and inspection
- Strong relationship building skills, with ability to interact effectively in a multifunctional, multicultural, growing organization
- Proficient with Microsoft Office
- Strategic thinking, strong organizational and analytic skills, project management, excellent verbal, written communication skills, attention to detail
- Experience with signal detection and risk management tools is a plus
Benefits
Our offer
We offer an exciting opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll have the chance to collaborate with an exceptional international team of people who are passionate about what they do. To top it off, we offer a highly competitive total rewards package (benefits and compensation), training that is tailored to your individual development, and career opportunities that match your ambitions. Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.
Source : Merus