Covance, India Hiring Drug Safety Project Manager| Apply Online
Covance, the drug development work of LabCorp, is known as a pioneer in drug development due to our exceptional men and women. At Covance, we embrace and celebrate different strengths, perspectives and experiences of our 20,000+ team members throughout the planet.
Job Id: 2018-22363
Job Title: Project Manager, Drug safety
Job Category: Clinical Operations
Position Type: Full-Time
Job Description:
- Handle and procedure expeditable adverse events to the necessary standard and apply them to the customer as well as the regulatory agencies (if needed ) within the agreed/stated timelines. The post holder is accountable for supplying this service to customers either as a service function to the customer project groups or as a standalone small business.
- Supply all customers, both external and internal, with the right quality of support in a protected and cost-effective manner.He/she is going to be expected to follow the lawful requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and EC (European Commission) Directives 1992/3 as registered in the firm’s Health & Safety Manual.
- Handle’Customer’ or’Project’ particular PV&DSS surgeries related to goods such as the whole adverse events procedure: that might consist of safety information accumulated from clinical trials or article advertising placing (i.e., unsolicited reports) for specified jobs.
Qualification:
- Relevant expertise includes expertise in the pharmaceutical, biotechnology, or CRO industry, partially in related areas like Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.
- Degree chosen to maintain one or more of these areas: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry. For PharmD, a 1-year residency of Partner can be considered important experience.
- *Security experience incorporates real experience processing AE/SAE reports, creating narratives, queries, working inside security databases, and expertise with regulatory entries.
Experience:
- Compliance with customer and international regulatory demands
- Great understanding of the applicable worldwide pharmacovigilance rules and regulations.
- Great knowledge of Good Clinical Practice (GCP) associated with clinical security documentation
- Great understanding of health and medication language
- Work collaboratively with PV&DSS Management’s staff
- Good verbal, written and presentation skills.
- Great communication.
- Management abilities
- Anticipate/identify issues and takes appropriate actions to fix.
- Awareness of Medical Device Reporting desired
- Awareness of aggregate reporting
