We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Location- #Delhi/NCR #Noida #Gurgaon #Delhi
Local Person-Pharmacovigilance- LQPPV-India
- Local Person for Pharmacovigilance (LPPV) in India acting as National Contact Person for Pharmacovigilance in INDIA acc. to applicable local regulation.
- The Local Person for Pharmacovigilance in India is responsible for the establishment and maintenance of the marketing authorization holder’s local pharmacovigilance system, and the performance of local Pharmacovigilance Operations.
- Close cooperation with the global PV system of the client as well as related global and local departments and functions
- Issue, review and maintain pharmacovigilance procedures (i.e. Standard Operating Procedures, Working Practices) related to the local tasks in connection with client procedures
- Close cooperation with the respective Deputy and providing the Deputy with information on relevant current PV activities
- Deputy is assuming responsibility in case of planned or unplanned absence
- Decisions regarding handling of safety-relevant issues in close cooperation with the client and global PV Regional Manager
- Full-fledged LQPPV, with experience in post-marketing and clinical trials. Relevant experience in:
- Local Literature Screening
- Local Risk Management Plan
- Additional Risk Minimization Measures
- Market Research and Patient Support Programs
- PV intelligence
- Signal detection
- PV awareness training
- Inspections and audits
- Gap assessment
- Digital and social media monitoring
- Other relevant aggregate reports
- ICSR management
- Autonomous, concentrated and high-quality work
- Ability to work in a team
- Sense of responsibility
- Hindi (native speaker)
- Proficient command of English
- University degree in Medicine, Pharmacy or Life Science
- Several years’ experience and profound knowledge in the field of pharmacovigilance
- Expertise, experience and knowledge regarding relevant global and local legislative and non-legislative guidelines on pharmacovigilance
- Detailed knowledge of related SOPs (global and local)
- Participation in all relevant courses of instruction such as internal trainings and applicable external courses
- Experience in all operative tasks that are performed by the members of the pharmacovigilance department
- Familiarity with industry principles of pharmacovigilance
- Ability to organise operational procedures and mange different tasks at the same time (e.g. effective coordination of personnel resources for time-conflicting projects)
- Ability to adjust rapidly to new, unknown, challenging situations
- Ability to analyze and solve problems and to develop possible solutions
- A collaborative and diverse work environment that values innovation and inclusivity.
- Opportunity to join a fast paced growing Global MNC and conquer exciting and varied challenges alongside a talented team
- Ability to work independently and collaborate effectively in a global, cross-cultural environment.
- Flexible working hours striking a good work life balance
- Business interaction with nearly all branches of the company across 5 continents
- A broad range of initiatives for personal development and professional training
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.