John Bond Email & Phone Number

Foster City, Ca, Us

South San Francisco, California, Us

Accountable for leading all safety deliverables for assigned products including the development and execution of the long-range safety strategic plans for the molecule, including all safety aspects of the product development plan and design, monitoring, analysis, and reporting of studies and other data sources throughout the product lifecycle.Accountable for leading the Safety Team for assigned molecules. Safety Teams include safety scientists, physicians, clinical scientists, epidemiologists, pharmacologists, medical writers, biostatisticians, safety licensing managers and other experts as required.Accountable for safety strategies and implementation in order to support dossier submission for marketing applications to global Health Authorities.Accountable for all representing aspects of safety for assigned molecules to the relevant internal Governance bodies.Accountable for leading pharmacovigilance strategies for assigned molecules by preparation of safety surveillance strategy and signal detection plan as well as tracking, evaluating and managing all potential safety issues, signals and risks.Accountable for overseeing the development and the execution of Risk Management Plan and all risk mitigation activities for assigned molecules.Accountable for the development and review of various periodic aggregate regulatory safety reports in accordance with international regulatory requirements.Accountable for the development of the Company Core Safety Information for assigned molecules.Accountable for safety content of clinical protocols, study reports, Investigators Brochure and other related documents to ensure alignment with CDP (Clinical Development Plan) for assigned molecules.Assist with recruitment, training, and coaching of PDSS staff members.Define portfolio responsibilities for other team members, direct, and manage other team members as appropriate.Author and contribute to scientific publications for scientific meetings/journals.

South San Francisco, California, Us

Accountable for leading the Safety Team for assigned molecules. Safety Teams include, safety scientists, safety operations physicians, clinical scientists, epidemiologists, pharmacologists, medical writers, biostatistics, safety licensing manager and other experts as required.Accountable for safety strategies and implementation in order to support dossier submission for marketing applications to global Health Authorities.Accountable for all representing aspects of safety for assigned molecules to the relevant internal Governance bodies.Accountable for leading pharmacovigilance strategies for assigned molecules by preparation of safety surveillance strategy and signal detection plan as well as tracking, evaluating and managing all potential signals, safety issues and risks.Accountable for overseeing the development and the execution of Risk Management Plan and all risk mitigation activities for assigned molecules.Accountable for the development and review of various periodic aggregate regulatory safety reports in accordance with international regulatory requirements and standard operating procedures.Accountable for the development of the Company Core Safety Information for assigned molecules.Accountable for safety content of clinical protocols, study reports, Investigators Brochure and other related documents to ensure alignment with CDP (Clinical Development Plan) for assigned molecules. Assist with recruitment, training, and coaching of PDSS staff members.Define portfolio responsibilities for other team members and direct and manage other team members as appropriate.

South San Francisco, California, Us

South San Francisco, California, Us

Switzerland 🇨🇭 , Ch

I was responsible for authoring periodic safety reports (DSUR, PBRER) and ensuring compliance with regulatory submission timelines. As the company DSUR subject matter expert, I was responsible for optimizing the DSUR process and contributing to other related initiatives, including the development of the PBRER. Working predominantly in the oncology therapeutic area, I also authored RMPs to support filings. I was the lead systems trainer within the team and trained and mentored new staff within Safety Documentation in general.

Switzerland 🇨🇭 , Ch

Drug Safety Operations are responsible for extraction, processing and medical evaluation of adverse event information from clinical and post marketing sources. As a Senior Drug Safety Specialist, I am responsible for the day to day running of Safety Operations, distribution of work, contributing to projects and ensuring we meet our regulatory obligations. I am currently the process owner for SUSARs, comparators, data capture, master labelling and I have previously held many other processes, including inbound receipt and triage, licensing exchange and EMA submissions. I have been involved in reconciliation between the clinical and safety databases, protocol review, safety management planning, SOP development, resolution of discrepancies, induction and developmental training and I am currently one of the three Welwyn based business experts for our new safety system, the ARIS suite. I joined drug safety as a member of one of the oncology teams, before joining the SUSAR team. I then went India to train our new BPO, TCS, in our principles, processes and systems. I was promoted to Senior Drug Safety Specialist with in the Receipt, Initiation and Distribution team, leading the team successfully through a significant personnel downsizing exercise whilst meeting the demands of an expansion in our responsibilities. I have now returned to one of the oncology teams. My role has provided me with an excellent knowledge of ICH guidelines, GCP, the European Clinical Trial Directive, and the Declaration of Helsinki and other regulations and guidelines relating to drug safety. I have an excellent technical knowledge of all of our processes and have produced significant improvements to many of them.

Switzerland 🇨🇭 , Ch

Mumbai, Maharashtra, In

Doctor Of Philosophy (Phd), Protein Crystallography

Bachelor Of Science (Bsc), Biochemistry