Pharmacovigilance Operations
Pharmacovigilance Operations
Posted on :
20-01-2025
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1 Vacancy
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Job Description
Job Title: Pharmacovigilance Operations (Senior Director Executive Director)
Job Location: Cambridge UK
Job Location Type: Hybrid
Job Contract Type: Fulltime
Job Seniority Level: Executive
Company Overview
At Merus we are advancing leadingedge 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.
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
Your Profile
We are looking for a candidate with:
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.
At Merus we are advancing leadingedge 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.
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 studyspecific 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 longrange department operational planning.
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
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.
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Employment Type
Full Time
Key Skills
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