PharmD Fellow Safety Analysis Scientist Full-time

Johnson & Johnson Innovative Medicine

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Post Doc – Drug Discovery & Pre-Clinical/Clinical Development

Johnson & Johnson Innovative Medicine is recruiting for a Global Safety Strategy & Risk Management (GSSRM) Pharm.D. Fellow, located in Lisbon, Portugal.

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 activities without defined processes.
• Support SMT activities (e.g. preparing and presenting data, compiling meeting minutes, updating signal tracking information).
• Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
• Provide presentations to internal and external stakeholders including guest lectures at universities, continuing education etc.
• Participate in rotational experience in other safety areas such as case processing, signal management etc.

Qualifications

Education:

• Pharm.D. Fellow candidates must have a Doctor of Pharmacy degree.

Experience and Skills:

• At least 2 years of industry experience or equivalent.
• Medical writing or pharmacovigilance experience preferred.
• Solid understanding of medical concepts.
• Excellent English verbal and written communication skills.
• Ability to understand and analyze complex medical-scientific data from a broad range of sources.
• Ability to interpret and present complex data to determine benefit-risk impact.
• Ability to effectively interact with stakeholders, including business partners.
• Ability to work in a matrix environment, proven leadership skills.
• Ability to plan work to meet deadlines and effectively balance multiple priorities.
• Proficiency in Microsoft applications (e.g. Word, Excel, and PowerPoint).

Requirements:

• Doctor of Pharmacy degree.
• At least 2 years of industry experience or equivalent.

Required Skills: Analytical Reasoning, Data Analysis, Data Reporting, Data Savvy, Researching, Safety Investigations, Serious Adverse Event Reporting, Technical Writing

The anticipated base pay range for this position is: €33,100.00 – €52,670.00

Benefits: In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees' and companies' performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees – and in some location's eligible dependents – can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.