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 companys 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 reputed company and post marketing safety data

Be the reputed company 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: Investigators 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 DMCs

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 reputed company Management Team (CMT) for assigned products

Contribute to the development and optimization of new tools and process

reputed company with safety and reputed company 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 reputed company 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 reputed company trial and post-marketing environments

Experience reputed company the reputed company 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 reputed company 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