Senior Pharmacovigilance & Benefit-Risk Physician
An internationally leading pharmaceutical company is seeking to recruit a Senior Pharmacovigilance & Benefit-Risk Physician to their office in Switzerland. Specialising in multiple therapy areas, the company boasts a superb pipeline with products that include treatments for diabetes, cancer, and asthma. This is an exciting opportunity to work with a company that operates in over 90 countries across the globe.
- Reviewing and overseeing safety data and safety signal management.
- Reviewing and/or signing off protocols, SAPs, clinical study reports, and other documents developed for submission to regulatory authorities.
- Preparing, reviewing, and signing off Aggregate Reports.
- Co-authoring Aggregate Reports (PSURs, DSURs) and Ad Hoc Safety Reports (e.g., Health Hazard Evaluations).
- Interacting with external experts, regulatory agencies, and partner/co-development companies.
- Reviewing safety data and participating in close escalation/continuation of vaccination decisions.
- Leading data analysis and writing of regulatory submission documents, for license application, variation activities, and for safety issues and questions from regulators.
- Directing the set-up of safety procedures and developing safety exchange agreements for co-development projects.
- Reviewing and performing clinical evaluation of individual case safety reports of SAEs and non-serious AEs occurring in association with assigned products, including providing input for medical coding of events according to standard MedDRA terminology, as well as data cleaning.
- Reviewing clinical protocols and other clinical development documents to ensure the adequacy of safety sections and assisting in the preparation of other safety documents, as required (e.g., the Investigator's Brochure (IB), CCSI).
- Developing and maintaining the Reference Safety Information for assigned products (e.g., Company Core Safety Information DCSI / CCSI, the respective information of the Core Data Sheet and Investigator's Brochure).
- Supporting the preparation of Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategies (REMS).
- Ensuring the integration or Benefit Risk Management framework/tools/expertise in global development and commercialisation process.
- Performing signal detection analyses and evaluating potential signals, incl. respective literature search.
- Preparing, with support from cross functions, ad hoc responses to regulatory authorities in response to specific queries from regulators.
- Providing input into responses to inquiries from internal sources, health care professionals, and other external sources.
- Providing support as required for licensing activities, regulatory authority inspections, company audits, and for project product recall activities.
- Performing pharmacovigilance training and mentoring of internal and cross-functional team members.
- Participating as a safety expert in Clinical Trial Teams, Clinical Development Teams, DMC meetings, and Investigator meetings, as applicable.
Skills and Requirements:
- At least 7 years' experience in pharmacovigilance, clinical research, or clinical development, including a minimum of 4 years in a global pharmacovigilance organisation.
- Experience in preparing responses to regulatory agencies on safety-related topics and aggregate analysis of safety data is required, ideally along with experience in filing vaccines products.
- Vaccines and/or biotechnology industry experience preferred.
- Strong investigational event and aggregate assessment/review/documentation skills.
- Extensive working knowledge of US/EU/APAC regulations and ICH guidelines.
- Proven experience in communicating with the FDA, EMA, and other global health authorities.
- Sound working knowledge of MedDRA coding.
- Excellent understanding of pharmacovigilance-related information systems.
- Expertise in Aggregate Report preparation and review.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Divya Mistry at +44 207 440 0636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.