Global Safety Strategy & Risk Management PharmD Fellow, Safety Analysis Scientist

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Career Programs

Job Sub Function:
Post Doc – Drug Discovery & Pre-Clinical/Clinical Development

Job Category:
Career Program

All Job Posting Locations:
Lisbon, Portugal

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

The GSSRM Pharm.D.

Fellowship is a training program designed to prepare the Fellow to become proficient at safety analyses and ad hoc report writing.

The Fellow, in partnership with the Medical Safety Officer (MSO) and under the mentorship and support from the preceptor, is responsible for the preparation of scientific safety analysis and evaluations, which are required for regulatory compliance and to aid in safety-related decisions for marketed products and products in development.

The Fellow will support product Safety Management Teams (SMTs) and work in close collaboration with other cross-functional safety partners to determine a product’s safety strategy, complete safety analyses and evaluations, proactively review safety data/lead safety data review meetings and interpret safety information to make a recommendation, supporting SMT deliverables as required.

The Fellow will gain a high-level understanding of case processing, safety surveillance, and review of medical literature and clinical trial data.

The Fellow will function under the guidance/support from the preceptor, and other team members, be able to link discussions to content, and deliver quality results with guidance from the preceptor and the team.

Key Responsibilities:



* Support safety evaluations, including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision.


* With mentorship from the preceptor and/or Safety Analysis Scientist (SAS), ensure high quality safety evaluations and reports with moderate comments from stakeholders and moderate revisions required.


* Provide support to SAS for novel projects, to bring value through completion of task-based activit...