Associate Director, US Pharmacovigilance
Parsippany, NJ 
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Posted 24 days ago
Job Description
Job Description:

As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first' philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.

As the Associate Director, US Pharmacovigilance, you will be responsible for overall compliance of tasks within applicable regulations, SOPs, and guidelines, provide Pharmacovigilance expertise and oversight to Ferring staff and serve as PV Representative for assigned Ferring projects.

With Ferring, you will be joining a recognized leader, identified as one of "The World's Most Innovative Companies" by Fast Company, and honored by Fortune with inclusion on its "Change the World List," for addressing society's unmet needs. Ferring US is also Great Places to Work Certified, distinguishing it as one of the best companies to work for in the country.

Responsibilities:

  • Responsible for PV Safety function for all Ferring Investigational and approved products.

  • Responsible for Adverse Event and Medical Device Reporting for all Ferring Investigational and approved products.

  • Serve as Deputy Local Safety Officer responsible for Pharmacovigilance safety function in the US.

  • Responsible for management of safety case reporting

  • Provide Pharmacovigilance expertise and oversight to Ferring staff

  • Responsible for overall compliance of tasks within applicable regulations, SOPs, and guidelines.

  • Mentor Ferring personnel and oversees Ferring training initiatives

  • Serve as PV Representative for assigned Ferring projects

  • Participate in the creation of Ferring policies and standard operating procedures.

  • Represent PV in cross-functional teams.

  • Manage Corrective Action Plans which result from either Health Authority inspections or internal Ferring quality audits

  • Oversee timely assessment and submission to FDA of ex US Adverse Event and Medical Device reports for Ferring Investigational products.

Requirements:

  • Doctorate degree (e.g MD, Pharm D, DVM) or HCP (RN, RPH).

  • 8+ years Pharmaceutical Industry experience required.

  • Management and leadership experience highly preferred.

  • With experience or working knowledge on Succession Planning.

  • Expertise in post-marketing and investigational Adverse Event Report assessment and review / documentation of individual adverse event report and aggregate safety data.

  • Working knowledge of Argus Safety database, preferred.

  • Experience with device safety is a plus.

  • In-depth knowledge of safety and Pharmacovigilance legislation at the U.S. FDA

  • Working knowledge of EU, and ICH regulations.

  • Ability to multitask and triage as needed.

  • Highly organized and demonstrates understanding of workflow prioritization.

Ferring + you

At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry's most impressive people, these are just some of the ways we live our "People First" philosophy.

Our Compensation and Benefits

At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $136,850 to $195,500, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.

Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 12 to 13 paid holidays per year. We are proud to offer 26 weeks of paid parental leave, learn more about the parental leave offering in our benefits package here.

Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws.

Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.

We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.

Location:Parsippany, New Jersey
We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Doctorate
Required Experience
8+ years
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