Director of Pharmacovigilance Operations

Director of Pharmacovigilance Operations

Location : NC-Clayton, US

Contract Type : Regular Full-Time

Area : R & D

Req Id : 536974

Summary : The Director is responsible for direct leadership over Grifols Biopharma pharmacovigilance and (PV) operations. Manages all adverse event investigations reported with Grifols Biopharma and Instituto Grifols' (IG) products reported in the US as well as other countries where the products are licensed. Manages PV compliance audits from domestic and foreign regulatory agencies.

Primary Responsibilities :

• Manage and process all adverse events (AE) reported with Grifols products in the US and other countries where the products are licensed.
• Investigate all adverse events reported with Instituto Grifols (IG) products and is a liaison between GBI and IG PV.
• Represent company at FDA Good Manufacturing Practice audits and other regulatory agency audits of PV procedures.
• Manage all AE investigations for the US and other countries where Grifols products are licensed.
• Prepare PV regulatory reports such as FDA's MedWatch reports, annual safety reports (e.g. PSURs, PSRs).
• Develop and update Standard Operating Procedures for processing AEs as necessary.
• Oversee AE trending reports and PV data analysis.
• Medical liaison with other company departments including quality, legal, regulatory and manufacturing.
• Triage all product complaints and forward the complaint to the appropriate team members.
• Provide scientific and / or technical advice and counsel regarding projects as needed.
• Maintain current knowledge of regulatory and industry standards, trends and advancements through independent reading and training.

Knowledge, Skills, & Abilities : Previous regulatory audit experience is preferred. Excellent problem solving and decision making skills, with demonstrate ability to use good judgment. Good organizational skills with ability to perform multiple priorities efficiently and effectively. Knowledgeable of Pharmacovigilance FDA, EMEA, ICH, GMP, GCP guidelines. Demonstrated experience with SOP and process creation. Demonstrated leadership skills. Flexibility and adaptability. Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner. Motivated self-starter, with ability to maintain a positive attitude. Demonstrated knowledge of applicable computer systems and applications such as Word, Excel etc.

Minimum Requirements : Minimum of a 4 Year Bachelor's degree in life sciences or related field. Minimum of 5 Years experience in Pharmacovigilance.

Occupational Demands : Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations and frequently travels within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.