Work as a Manager in Drug Safety at Covance

Post : Manager Drug Safety
Job Summary
The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job.
• Line manage PV&DSS staff including performance reviews, human resource issues, and assist Senior PV&DSS Management in assigning resources to projects.
• Manage the overall PV&DSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post mrketing setting (i.e., unsolicited reports) for specified projects.
• Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. The post holder is responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business.
• Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
• He/she will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and EC (European Commission) Directives 1992/3 as documented in the Company's Health & Safety Manual

Candidate Profile

• Level of education required ( or experience level which may be substituted for level of education)
• Professional designation/certification/licenses required
• Non degree +10 years safety experience
• Assoicate degree +8-9 years safety experience*
• Associate degreee RN=7-8 years safety experience*
• BS/BA +6-7years safety experience*
• MS/MA +5-6 years relevant experience**(4-5years safety experience)
• PharmD+3-4 years relevant experience ** (2-3 years safety experience)
• For Pharm D, a one year residency of fellowship can be considered relevant experience
• Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences and Chemistry
• *Safety experience includes actual experience processing AE/SAE reports, generating naratives, queries, working within safety databases, and experience with regulatory submissions.
• **Relevant experience includes experience in the pharmaceutical, biotechnology or CRO industry, partly in related areas such as Medical affairs, Clinical Data Entry and Clinical Data Management , Clinical Data Monitor, Regulatory Affairs, or Quality Assurance

Experience

• • At least 4 years line management and/or project management experience.
• • Industry experience of which 6 years is relevant to pharmacovigilance/drug safety knowledge.
• • Good verbal, written and presentation skills.
• • Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.
• • Work collaboratively with PV&DSS Management's team
• • Strong leadership capabilities
• • Excellent communication
• • Overall departmnetal resource
• • Client service focus
• • Ability to multitask and priortize
• • High degree of accuracy with attention to detail
• • Ensure client and global regulatory compliance
• • Will present and share useful business information across departments and functions
• • Anticipate /identify problems and takes appropriate action to correct
• • Knowledge of medical and drug terminology
• • Knowledge of Good clinical practice related to clinical safety documentation
• • Knowledge of world wide regulatory requirements and reporting of adverse event for both marketed and investigational products
• • Knowledge of Medical Device Reporting desirable
• • Knowledge of agggregate reporting
• • Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial
• • Financially intuitive
• • Profiecient knowledge of ICH Guidelines
• • Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance

Additional Information
Experience : 2-5 years
Qualification : Pharm.D
Location : Bangalore
Industry Type : Pharma
Functional Area : Drug Safety
End Date : 25th August, 2018