Pharmacovigilance Benefit Risk Physician
If you are interested in finding out more about this excellent opportunity, please give me a call on 01142945005 or alternatively please send me an email at Jcoomey@acr-uk.
- Responsible for clinical review and evaluation of individual case safety reports of SAEs and non-serious AEs occurring in association with assigned products, including medical review of SAEs and nonserious AEs occurring during clinical development and postmarketing surveillance of assigned products as well as input for medical coding of events according to standard MedDRA terminology and data cleaning.
- Responsible for review of clinical protocols and other clinical development documents to ensure adequacy of safety sections, assists in the preparation of other safety documents, as required (e.g., the Investigator's Brochure (IB), Informed Consent Forms (ICF), Case Report Forms (CRF)).
- Responsible for the preparation of Aggregate Reports: Co-authors Aggregate Reports (PSURs, DSURs) and Ad Hoc Safety Reports (e.g., Health Hazard Evaluations).
- Responsible for the development and maintenance of 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).
- Responsible for the preparation of Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategies (REMS): Assists in the development and maintenance of RMPs and REMS, including the coordination with other line functions for associated activities such as updates, ongoing tracking of commitments and effectiveness measures, and provides analytical input for known and potential risks defined in RMPs and REMS .
- Responsible for safety signal detection and evaluation of assigned products , incl. respective literature search
- Chairs Vaccine Safety Team (VST) and Safety Review Team meetings.
- Prepares, with support from cross functions, ad hoc responses to regulatory authorities in response to specific queries from regulators.
- Provides input to responses to inquiries from internal sources, health care professionals, and other external sources as well as support for licensing activities, regulatory authority inspections, company audits, and project product recall activities, as requested.
- Provides Pharmacovigilance training and mentoring of internal and cross-functional team members.
- Vaccines and/or biotechnology industry experience preferred
- Minimum 5 years of pharmaceutical and/or biotechnology industry experience in Pharmacovigilance functioning as a Pharmacovigilance Physician.
- Minimum 8 years of experience in clinical trials and postmarketing pharmacovigilance
- Minimum 8 years of experience in signal detection and evaluation.
- Strong investigational event and aggregate assessment/review/documentation skills.
- Strong working knowledge of US/EU/APAC regulations and ICH guidelines.
- Strong experience in risk management plan preparation and review, including European Union Risk Management Plans (EU - RMPs) and US REMS.
- Experience in communicating with the FDA, EMA, and other global health authorities.
- Sound working knowledge of MedDRA coding.
- Understanding of pharmacovigilance-related information systems.
- Oversight of the pharmacovigilance and risk management strategy with responsibility for the medical safety content of all documents required to implement and monitor the progress of risk management plans and for responses to ad hoc safety issues to regulatory authorities.
- Expert in Aggregate Report preparation and review.
- Proven collaborative internal relations with Clinical Development, Regulatory Affairs, Medical Affairs, Quality and Legal Counsel.
- High integrity, sense of urgency, ability to recognize time sensitivity, willingness to be a "player/coach".
- Excellent English written and verbal communication skills, additional languages (e.g., Spanish, Japanese, German) desired.
- Dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging circumstances.
- Demonstrated success in building effective matrix working teams, systems, and processes; proven ability to identify, select and manage a variety of external resources.
- Leadership/managerial experience preferred.
Requires approximately 20% - 30% travel.