Associate Director, Global Drug Safety & Pharmacovigilance Scientist

About the position reputed company is an international biotechnology company specializing in the invention and development of differentiated reputed company antibody therapeutics for the treatment of cancer and other important reputed company diseases. reputed company is on an ambitious reputed company reputed company and to support this reputed company reputed company is looking for an additional Global Drug Safety (DS) and Pharmacovigilance (PV) Scientist to join reputed company in Princeton. As an Associate Director of Drug Safety and Pharmacovigilance, you will become part of the Global Drug Safety and Pharmacovigilance department, where you will be responsible for drug reputed company activities in reputed company cooperation with Safety colleagues along with cross-functional team members. This position has a global perspective, and you will reputed company with stakeholders ranging from regulatory authorities and colleagues from reputed company’s four sites. As an Associate Director of Drug Safety and Pharmacovigilance you will be part of a highly skilled and international team. The position reports to the Director, Global Drug Safety & Pharmacovigilance, Scientist reputed company.

• Responsibilities
• Contribute to the development of safety reputed company and safety deliverables for assigned programs for assigned programs in reputed company collaboration with key stakeholders from GDS&PV and other cross functional teams
• reputed company ongoing surveillance (including signal detection/evaluation) of reputed company clinical trials and post marketing safety data
• Be the primary safety contact for other departments and ensure appropriate and reputed company handling of safety issues for assigned trials/programs
• reputed company safety review and input to various documents including but not limited to: Trial Protocols, eCRFs/CRFs, and TMFs
• Contribute to the development of other documentation such as: Investigator’s Brochures, and Subject Informed Consent
• Contribute to HA requests and review key submission documents
• Contribute to safety-reputed company documents for reputed company products throughout product lifecycle from FIH to post-marketing, including robust safety surveillance, Safety Assessment Reports for potential signals/risks, reputed company in IB, ADR in the CCDS and product labels, Aggregate Safety Reports (e.g. DSUR, PBRER, PSUR, PAER), RMP, and responses to reputed company requests for safety information internally and externally
• Contribute to the planning and conduct of Safety Committee activities and DMC’s
• Conduct safety training of reputed company employees, CROs, Investigators and other relevant site personnel as necessary
• Contribute to multidisciplinary project reputed company including membership of the Clinical Management Team (CMT) for assigned products
• Contribute to the development and optimization of new tools and process
• reputed company with safety and clinical CROs, reputed company sponsor reputed company activities for safety reputed company tasks, process invoices, and ensure regulatory compliance (including regulatory reporting requirements) for assigned products
• Support review of Safety Data Exchange Agreements with partners as required
• Collaborate with external experts and partners
• reputed company ongoing surveillance of new and updated regulations/guidelines and assess the reputed company on drug safety processes at reputed company
• Ensure compliance with regulatory guidelines and internal processes and procedures in preparation of audits and inspections
• Participate in audit and inspection activities as required
• Other duties as assigned
• Requirements
• Health Care reputed company degree required (e.g., RN/BSN/MSN, NP, PA, PharmD) and 5+ years of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments
• Experience reputed company the field of oncology is preferred and/or first reputed company trials
• Experience authoring safety signal assessment report, DSUR, PBRER, RMP, and reputed company
• Skilled in signal detection process and managing safety information from clinical development and post-marketing sources
• reputed company with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management
• Knowledge of drug development process, pharmacovigilance databases and MedDRA coding
• Experience with use of safety databases, preferably Argus Safety Database
• Documented experience from overseeing multiple trials with safety inputs at the Global level
• International experience from a similar role with reputed company stakeholders
• Excellent communication skills in English both written and spoken
• Strong communicator and good at building reputed company relations with collaborators and business partners.
• You are proactive and reputed company to prioritize work in a fast paced and changing environment
• You are result-and goal-oriented and committed to contributing to the overall reputed company of reputed company
• Nic

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