Director, Drug Safety Pharmacovigilance (Investigational Products)

Job Description
Job Description:

The Director, Drug Safety Pharmacovigilance is responsible for the PV Safety function for all Ferring (FPI and FIPCUS) Investigational products. Also responsible for Adverse Event and Medical Device Reporting for all Ferring (FPI and FIPCUS) Investigational. This position will also serve as Local Safety Officer responsible for Pharmacovigilance safety function in the US for products under development.

Responsibilities

1. Serves as Pharmacovigilance safety expert across all Therapeutic Areas for all Ferring Investigational products and represents PV Safety in cross-functional teams including Business Development.
2. Performs case assesmentfor Medical Device reports and Drug Adverse Event reports, as needed for all Ferring Investigational products.
3. Serves as Safety Monitor for US Clinical Trials and addresses safety issues for all products in development
4. Reviews safety sections of IND/IDE protocols
5. Reviews/contributes to Statistical Analysis Plan for clinical studies
6. Provides analysis of similar events, for serious adverse reactions from Clinical Trials, as required for IND submissions
7. Reviews/contributes to all safety documents pertinent to NDA filing.
8. Provides safety information to product labelling for new NDAs and supports product labelling changes through life-cycle of product
9. Responsible for safety sections of IND/NDA Annual reports and Annual Product review of all Device related adverse events.
10.Manages Corrective Action Plans which result from either Health Authority inspections or internal Ferring quality audits
11.Risk Evaluation and Mitigation for new NDAs and emerging safety signals for all Ferring Investigational products.
12.Oversees timely assessment and submission to FDA of ex US Adverse Event and Medical Device reports for Ferring Investigational products.

Qualifications

· MD or DO degree required - Board Certified preferred
· Clinical practice experience, 5 - 10 years minimum beyond residency required
· 7+ years Pharmaceutical Industry experience
· 5+ years management and leadership experience
· Expertise in post-marketing and investigational Adverse Event Report assessment and review / documentation of individual adverse event report and aggregate safety data.
· Expertise in MedDRA coding and case series retrieval strategies.
· Experience in large scale electronic data storage and retrieval systems. Working knowledge of Clintrace database, preferred
· Experience in safety reviews of IB’s, protocols, final CSR’s and summaries of safety data.
· In-depth knowledge of safety and Pharmacovigilance legislation at the U.S. FDA, EU, and ICH level;

Company

Ferring Pharmaceuticals, Inc.

Job Code

State or Province

New Jersey

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