Associate Director, Drug Safety & Risk Management

Location
Lake Forest, IL, United States
Posted
Apr 12, 2018
Ref
1111XX
Discipline
Clinical, Drug Safety
Required Education
Doctorate/PHD/MD
Position Type
Full time
JOB SUMMARY
Responsible for executing and managing pharmacovigilance activities that include adverse event reporting, safety assessments, signal detection and aggregate reporting in compliance with applicable FDA and global regulations and Depomed standard operating procedures and guidelines. Responsible for internal processes that include the ongoing maintenance of adverse event workflow, department policies and standard operating procedures, and manage the department relationship with business partners. Externally work with business partners to ensure execution of contracts that include, but are not limited to safety vendor/s, companies with whom we have PV agreements to meet global regulatory reporting requirements and support other Depomed business areas. Assist with the preparation of internal and external reports (e.g. PADERs) and production and distribution of routine pharmacovigilance metrics. Help drive internally, and collaborate with external partners, in the development and execution of risk management activities including Risk Evaluation and Mitigation Strategies (REMS) programs. on projects and activities to support Depomed's REMS programs.

ESSENTIAL JOB FUNCTIONS
• Review adverse event information received by Pharmacovigilance vendors for clinical accuracy, completeness and consistency
• Report within timelines CIOMS
• Review submissions to FDA made on behalf of Depomed for clinical accuracy, completeness and consistency
• Reviews case information for appropriate distribution to internal and external business partners
• Assists in the compilation of individual and aggregate reports (PADERs, etc.) per U.S. regulations
• Act as primary point of contact for safety reporting in ongoing trials
• Represent Clinical Affairs on relevant safety monitoring boards, if requested
• Work with Clinical Ops to draft and finalize Safety Management Plans
• Act as a liaison with internal departments and external business partners on Drug Safety and Pharmacovigilance operation management issues and clinical study related activities
• Direct vendor in signal detection activities
• Ensure compliance with corporate and departmental standard operating procedures
• Support Clinical Affairs in the development and maintenance of relevant safety SOPs
• Lead corporate training initiatives on safety reporting
• As an individual contributor, may serve as a project manager for functional projects or workflows
• Contribute data to product labelling efforts where appropriate

Requirements

ADDITIONAL RESPONSIBILITIES/DUTIES

EDUCATION AND EXPERIENCE
• Advanced degree in a health related (e.g., RN/BSN, RPh/PharmD, MD) or biological science related field (e.g., PhD. in Biology) and 5-7 years of experience, or equivalent combination of education and experience
• 5+ years in Pharmacovigilance & Risk Management
• Experience in phases I-IV drug safety surveillance
• Knowledge of FDA and international adverse event reporting regulations per ICH guidelines and the ability to interpret and apply applicable regulations to resolve issues
• Preferably knowledge of Pain Therapy and CNS disease states
• Advanced working knowledge of clinical and post-marketing database systems
• Proficient in MedDRA coding of medical terminology and WHO-DD drug classification
• Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
• Experience with preparation of investigational and post-marketing regulatory reports

SKILLS AND ABILITIES
• Excellent oral and written communication skills
• Proven ability to critically evaluate and summarize clinical and scientific data
• Highly organized and demonstrates consistent attention to detail
• Must demonstrate accountability for delivery of results and have good problem-solving and decision making skills
• Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines
• Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required
• Must have the ability to operate in fast-paced, timeline-oriented, team environments/matrix organizations
• Proficiency in standard desktop software programs (Word, Excel, Outlook)

DEPOMED COMPETENCIES INCLUDE
• Integrity
• Decisions & Judgment
• Ownership & Initiative
• Adaptability & Change Readiness
• Teamwork & Collaboration

PHYSICAL/MENTAL DEMANDS
• Sitting - Approximately 85%
• Standing/ walking - Approximately 15%
• Repetitive motion: Substantial movements of the wrists, hands, and/or fingers for sustained periods of time while keyboarding, texting, etc.
• Visual Requirements: Able to see and read PC screens read fine print, etc.
• Hearing Requirements: Able to understand what employees and others are saying
• Lifting: Light lifting of up to 15 pounds
• Travel: Ability to fly across the country and navigate to field meetings / events

About Us

THE COMPANY

Depomed is a leading specialty pharmaceutical company committed to putting the Patient First in everything we do; with a focus on enhancing the lives of patients, families, physicians, providers and in payors through commercialization of products in the areas of pain and neurology, and developing drugs in areas of unmet medical needs.

Depomed currently markets three medicines focused on neuropathic pain and migraine through its Neurology and Pain Business and has an emerging Specialty Business focused on orphan drug indications and areas of unmet medical need.

Depomed has a clear THREE PILLAR strategy for growth:
MAINTAIN a strong/profitable NUCYNTA franchise through a commercialization agreement with Collegium, GROW the Neurology and Pain Business and BUILD a new Specialty Business through a recent Cosyntropin transaction. The company's strategy is to continue to identify, license and develop new products-that offer enhanced therapeutic options to patient populations that may be underserved by existing therapies.

As part of the transformation strategy, Depomed will be relocating its headquarters to northern Chicago, Illinois. Additional information about location will be shared during the interview process.

Depomed is an AA/EEO/Veterans/Disabled employer