Vacature (PV Associate

Pharming is seeking to hire a Pharmacovigilance (PV) Associate to bring case processing of all (S)AE reports for Pharming product(s) in the ARGUS safety database including conduction of all follow-up queries, requests, and working with PV colleagues on assigned tasks. Our goal is for the PV Associate to work collaboratively among our Pharmacovigilance Department. Successful execution will involve a willingness to adjust to multiple demands and shifting priorities with confidence and professionalism. The position reports to our Senior PV Manager and will not have any direct reports.

The Pharmacovigilance (PV) Associate will be responsible for a wide variety of matters in support of Pharming's growth as we increase the number of both pipeline and marketed products.

Core functions include:

• Review, triage, verify, book-in, and data enter reported (S)AEs associated with the use of Pharming's product(s) both in development and authorized as per the compliance requirements of the competent authorities.
• Perform case assessment including determining case validity and seriousness.
• Determine and perform appropriate case follow-up activities including generation of follow-up requests via fax, phone, mail, or e-mail and product complaint notifications to consumers, HCPs, Specialty Pharmacies and/or vendors.
• Coordinate and schedule trainings for internal and external stakeholders as per PV managers' requests.
• Collaborate with the PV team and ensure all assigned tasks (e.g., training) are completed within defined timelines.
• Other PV tasks as assigned or requested by the US PV Team and/or VP Pharmacovigilance.
• This is a hybrid role; 2 to 3 days at the US HQ in Warren, NJ.

Minimum Qualifications:

• Bachelor of Science Degree in the life sciences, pharmacy, nursing or equivalent.
• Minimum of 1+ years of industry experience in pharmacovigilance and drug safety.

Preferred Qualifications:

• Extensive knowledge of pharmacovigilance especially case processing including MedDRA coding.
• Extensive knowledge of the ARGUS safety database.
• In depth understanding of good pharmacovigilance practices and current drug safety regulations.
• Good knowledge of GCP/ICH guidelines.
• Computer proficiency.

Compensation & Benefits:

• Flexible hybrid work a health work-life balance.
• Competitive compensation package including annual target bonus.
• Long-Term Incentive Program
• 401(k) plan with company match
• Paid-Time Off Days
• 16 Company Holidays per year (typically last week of December up until New Year's Day)

• Excellent Healthcare Plans including Medical, Dental and Vision.
• Flexible Spending Accounts for Medical and Dependent Care.
• Company-provided Life Insurance, Short-Term and Long-Term Disability Plans.
• Accident, Hospital Indemnity and Critical Illness Plans.
• Pet Insurance Plan.
• On Premise Fitness Center.
• Health & Wellness Program.
• Choice of Mobile Phone for Work Use or Cell Phone Stipend.
• Pharming Academy - Continuing Learning & Development Program.

Pharming is committed as an Equal Opportunity and Affirmative Action employer for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, genetic information, sexual orientation, marital status, race, religion, color, national origin, disability, protected Veteran status, age, or any other characteristic protected under applicable law.

An applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request via email to .

Unsolicited resumes from agencies should not be forwarded to Pharming. Pharming will not be responsible for any fees arising from the use of resumes through this source. Pharming will only pay a fee to agencies if a formal agreement between Pharming and the agency has been established. The Human Resources/Talent Acquisition department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Functie:	pv associate
Startdatum:	23-12-2023
Ervaring:	Ervaren
Educatielevel:	HBO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

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