Beautifully comprehensive skin care takes a deeper commitment. As a privately held, fully integrated global skincare company, Crown Laboratories is dedicated to developing and providing a diverse portfolio of safe and effective scientific solutions for life-long healthy skin. Our three business units, aesthetics, premium beauty, and therapeutic skincare products demonstrate Crown’s mission of Skin Science for Life, which is the foundation of our commitment to partnering with consumers throughout their skin health journey, giving skin what it needs to be its healthiest and best, at every age.

Crown Laboratories, Inc. is currently recruiting for aPharmacovigilance Specialist

This position will be located in Johnson City, TN / Dallas, TX - (On-Site)

*Travel Required: 25%*

Job Description:

Crown Laboratories is looking to hire a pharmacovigilance specialist (a.k.a., a drug/device safety officer). This individual would work under the supervision of the Medical Affairs and Clinical Development department and would be responsible for monitoring and reporting the effectiveness and any adverse effects or side effects of pharmaceutical products/OTC/Medical Devices on the market in the general population and in hospitals and research trials. They will liaise closely with medical and drug company representatives, patients, doctors and other healthcare professionals to record the effectiveness of drugs and other treatments. The successful candidate will be able to provide data that is meticulously recorded, analyzed and processed because the informed opinions of pharmacovigilance specialists will help Crown maximize product safety and performance, and cut down on adverse effects.

Primary Responsibilities:

Management of Adverse Events (AEs)

• Accurately evaluates potential AE cases received from healthcare professionals and consumers
• Documents cases according to established procedures.
• Accurately records product safety information and product-quality complaints.
• Appropriately assesses case severity with Medical Affairs in order to prioritize follow-up.
• Reviews data against source documents.
• Submits data in a timely manner following established procedures.
• Properly assesses submission eligibility on a case-by-case basis as per regulations.
• Diligently prepares and checks required documentation.
• Identifies appropriate regulatory agency directions.
• Works with Crown Regulatory to carefully review and document regulatory agency requests.
• Prepares responses based on requests.
• Prepares clear periodic reports as needed.
• Diligently assesses product safety profiles.
• Recommends action based on identified risks.
• Minimize the risk of serious side effects
• Helps draft safety-profile assessment reports.
• Files case reports according to the appropriate process
• Creates SOPs and prepares them for routing/reviews
• Responsible for updating www.clinicaltrials.gov with Crowns’ Clinical Studies

Involved in Clinical Study Activities

• Identifies the roles and accountabilities of participating clinical study resources.
• Thoroughly document training available to concerned resources.
• Provides resources with relevant training on study protocol requirements
• Provide guidance when working on clinical trials of new drugs.
• Plays an active role in reviewing contracts with investigators to ensure proper compliance and notifications.
• Submits pharmacovigilance data in a timely manner.
• Verifies the risks listed in the investigator’s brochure.
• Actively participates in the validation of study reports.
• Accurately assesses the seriousness of study-reported cases and maintains strict follow-up of treated cases.
• Verifies data quality against source documents regarding safety and AEs.
• Ensures the accuracy of the safety information.
• Follows up on clarifications pertaining to case reports, if necessary.

Assurance of Pharmacovigilance Compliance

• Creates pharmacovigilance procedures based on overall company procedures and prevailing regulations.
• Provides training to personnel based on the training plan.
• Effectively manages/provides training documentation to Quality.
• Monitors pharmacovigilance procedures according to contracts, procedures, regulations, and directives.
• Verifies data according to information sources prior to undertaking case reconciliation.
• Properly reconciles cases and follows up on issues with various departments.
• When necessary, plays an active role in the preparation, conduct, and monitoring of audits and inspections.
• Archives documents according to prevailing standards

Job-Related Qualifications / Skills:

Candidates must have:

• Degree at BSc/BA level or equivalent
• Minimum 2 years of experience with product safety in a pharmaceutical, biotech, medical device, or clinical research organization with client-facing responsibilities
• Understanding of pharmacovigilance practices and translation to technology and innovative approaches
• Excellent client interaction and communication skills. Ability to build trust with clients through successful engagements
• Open and honest communication with all colleagues; willingness to be supportive
• Ability to multi-task in a highly organized manner and to prioritize deliverables
• Demonstrable self-managing/self-motivating skills
• Clear ability to operate within a team
• Willingness to mentor and cross-train colleagues and to receive cross-training as necessary
• Proven ability to deliver excellence even under tight deadlines
• Ability to work successfully within cross-functional teams
• Ability to solve complex issues

Candidates Should Have

• Microsoft Office
• Statistical analysis capabilities
• Familiarity with Unix and Windows
• Excellent oral and written communication skills
• Forward-thinking and self-motivating to enhance skill sets
• Willingness to travel
• Project management experience

NOTE: This job profile is intended to provide an overview of expected job duties and requirements. It is not intended to be a contract of employment, explicit or implicit. All contents are subject to change at the sole discretion of the company. Cooperation is expected of all employees. Other duties may be assigned as needed.

We offer a competitive benefits package including, health, dental, paid time off, vision, short/long term disability and 401(k) w/match.

Equal Opportunity Employer

Learn more about the Crown family of products:

Crown Therapeutics: maker of PanOxyl®, the #1 acne wash; Blue Lizard® Australian Sunscreen, the #1 Pediatrician recommended mineral-based sunscreen brand; and Sarna®, the #1 Dermatologist recommended topical anti-itch brand and National Seal of Acceptance from the NEA, and more.

Crown Premium Skincare: includes StriVectin, comprised of a broad range of award-winning skincare solutions for all skin types, tones, and ages; and Vita Liberata, a multiple award-winning sunless tanning brand.

Crown Laboratories does not accept unsolicited resumes from individual recruiters or third-party recruiting agencies in response to job postings. No fee will be paid to third parties who submit unsolicited candidates directly to our hiring managers. All candidates must be submitted by approved Crown Laboratories vendors who have been expressly requested to make a submission by our HR team for a specific job opening. No placement fees will be paid to any firm unless such a request has been made by the Crown Laboratories HR team and such candidate was submitted to the Crown Laboratories HR team.

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