Pharmacovigilance Scientist II / Drug Safety Aggregate ReportsĀ (REMOTE-WORK)

Pioneer Data Systems Inc

Job Description

Our client, a world-leading Pharmaceutical client in Horsham, PA is currently looking for a Pharmacovigilance Scientist II / Drug Safety Aggregate Reports (REMOTE-WORK) to join their expanding team.


Position Details:

Job Title: Pharmacovigilance Scientist II / Drug Safety Aggregate Reports (REMOTE-WORK)

Duration: 6 months contract, extendable up to 24 Months

Location: Horsham, PA


Note:

The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.

You may participate in the company group medical insurance plan


Job Description:

Senior Scientist (Pharmacovigilance Scientist ll)


Position Summary:

The Sr. Scientist will be responsible for core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned reports (medium to large volume, standard complexity).

The Sr. Scientist will have in-depth product knowledge and will support Safety Management Team (SMT) deliverables as required.

Daily activities involve planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, and project management/coordination of strategic safety documents.

The Sr. Scientist will partner with team members, stakeholders including Medical Safety Officers (MSOs), and a vendor.


Job Requirements

Principal Responsibilities:

Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate

Collaborate with Therapeutic Area Safety Head (TASH)/MSO/Safety Surveillance Physician (SSP) and other stakeholders on strategy development

Initiate/Conduct/Oversee searches of internal and external databases

Perform and/or lead aggregate safety analysis and case level review

Author, contribute, and coordinate the preparation of core safety deliverables

Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met

Partner with vendor to develop reports/deliverables

Provide SMT support as needed

Act as ad hoc member for assigned products as appropriate

Training/Meetings/Department initiatives

Participate in cross-functional training of relevant stakeholders

Attend departmental meetings and trainings

Participate in department and/or cross-functional initiatives

Decision-Making And Problem-Solving

Recognize potential issues and or safety issues and escalate to the attention of the report owner, line manager, or MSO

Ability to understand nature of adverse drug reactions and complex associations

High level of flexibility and ability to (re)prioritize work of oneself and others

Attention to detail and ability to analyze data in broader context

Ability to work across multiple functions and therapeutic areas

Review regulatory assessor comments/requests and accommodate/address as appropriate with guidance


Reporting Relationships

This position reports into the Pharmacovigilance Evaluation and Reporting Director, TA Lead or designee


Requirements:

Bachelor's Degree in Health or Biomedical Science (6-8 years industry experience or equivalent)

Advanced Degree Preferred in Health or Biomedical Science (4-6 years industry experience or equivalent)

Clinical/Medical writing or PV experience preferred

Strong English verbal and written communication skills


Other Comments:

Scientific Skillset: Comprehensive Analytic and Conceptual Skills

Independence: Moderate independence or Independent; (Contributor/Co-lead/Lead)

SME-In depth product knowledge of assigned products

Core SMT member or SMT support when needed

Working knowledge of applicable global, regional, and local regulatory requirements (eg, ICH guidelines)


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