Pharmacovigilance (PV) Scientist-Hybrid

Job Description: Pharmacovigilance (PV) Scientist

Employment Type: Long term contract

Location: Hybrid in Cambridge, MA

Required: Experience with ARGUS and Empirica PSUR, DSUR for Aggerate reporting. Clinical & analytical background.

Pay: $70-$80 per hour


Position Overview:

We are seeking a highly skilled and experienced Pharmacovigilance (PV) Scientist to join our team. This role is pivotal in ensuring the safety and efficacy of pharmaceutical products through robust aggregate reporting and data analysis. The ideal candidate will have a strong clinical background and expertise in ARGUS, Empirica, PSUR, and DSUR processes. This position demands a detail-oriented professional with excellent analytical and authoring skills.


Key Responsibilities:

• Prepare, author, and review aggregate reports, including Periodic Safety Update Reports (PSUR) and Development Safety Update Reports


• Contribute to signaling and data mining activities utilizing internal and external sources of data. Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA required.

Education:

Degree in a medical or healthcare related discipline (MSN RN, PharmD, Physician Assistant, MD) is required



Experience:

A minimum of three to five years in the pharmaceutical industry with experience in drug safety/pharmacovigilance.

Strong skills and experience in;

Supporting the development and application of business process improvement methodologies and/or developing ideas into practical business solutions.

Ability to work in a matrix environment in accordance with the company leadership commitments and values. Preferably with experience of working across diverse geographic areas, business settings and cultures.

Pharmacovigilance, safety, or clinical science, and/or other relevant areas of clinical biopharmaceutical development or medical affairs.

Knowledge of Argus, Arisg Safety Databases

Knowledge of Signaling tools (e.g. Empirica, Spotfire)

Experience and or understanding of regulations in the pharmaceutical industry.

Skills in developing/implementing data displays (Dashboards) of data for signaling, compliance and departmental KPIs & QPIs

Knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements

Strong planning, organization, written and oral communication skills

Experience in clinical patient care a plus


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About Advantage Technical

With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit .


Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.


All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.

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