Associate Director, Pharmacovigilance / Product Surveillance - 1623BR
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Lake Forest, IL 60045
The Associate Director, Pharmacovigilance / Product Surveillance has responsibility for the pharmacovigilance risk management activities of commercial, development and investigational products on a global level, in addition to overseeing routine complaint management process. The position reports to the Executive Director, Global Quality Compliance.
Duties & Responsibilities
• Develop proactive risk management strategies for key marketed and/or investigational products
• Provide and communicate regularly with internal and external stakeholders and develop quality ICSR case processing and reporting metrics. Perform reconciliation of AE’s/SAEs. Contribute to solving reconciliation coding issues/discrepancies
• Contribute to the resolution of issues from cases of high complexity through medical / safety expertise and leading team interdepartmental interactions. Perform quality review of vendor case processing and medical review task against Drug Safety process and procedures and recommend corrective actions if required
• Conduct evaluation of other relevant safety information (e.g. from non-clinical studies and product quality complaints) as required
• Assure required safety submissions are of highest quality and submitted within regulatory timelines, including DSURs and additional ad hoc safety reports.
• Perform other drug safety operations tasks as applicable
• Directly manage all contractors, service providers and internal employees that are part of the Pharmacovigilance/Product Surveillance team
• Develop SOPs as needed. Assure Safety and Safety Service Provider SOPs, Safety Management Plans, Organization Chart, CV’s and Job descriptions are up to date and readily available for regulatory inspection
• Serve as point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility.
• Plan, manage / perform and monitor all pharmacovigilance/complaint management activities
• Review and medical-scientific input to regulatory documents such as:
? Periodic Benefit Risk Evaluation Report / PADERs
? Development Safety Update Reports
? Risk Management Plans
? Clinical Overview Statements
• Provide updates of the assigned drug’s safety profile to senior management and recommend pharmacovigilance / risk management activities to BI decision making bodies and the EU QPPV
• Represent Pharmacovigilance in internal and external committees & bodies.
• Contribute to the further development of pharmacovigilance within the company by staying abreast of state of the art methodology, changes in the regulatory environment and developments and trends in healthcare system and society.
* RPH, PharmD or Nurse Practitioner (NP) required
* At least 8 years’ relevant pharmaceutical industry experience/expertise, with significant previous experience in pharmacovigilance in an operational position
* Ability to establish effective working relationships with people in a wide variety of disciplines and backgrounds; manage and prioritize multiple projects and demands simultaneously; rapidly adjust to changing priorities and work effectively under pressure
* Demonstrated knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments
* Contribute to contractual issues with potential commercial partners
* Proven ability to strategically apply principles of clinical assessment of adverse events in the pharmaceutical industry
* Robust knowledge of MedDRA dictionary with relevance to adverse event coding
Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.