Director of Pharmacovigilance Operations

Grifols SA-posted about 1 month ago
Full-time • Director
Onsite • Clayton, NC
5,001-10,000 employees
Merchant Wholesalers, Nondurable Goods
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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. 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.

  • 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.
  • Minimum of a 4 Year Bachelor's degree in life sciences or related field.
  • Minimum of 5 Years experience in Pharmacovigilance.
  • 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.
  • Previous regulatory audit experience is preferred.
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