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Team Leader, Drug Safety and Pharmacovigilance in Hyderabad

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WDB Holdings Co., Ltd. / WDB Singapore Pte. Ltd.

5 – 10 yrs Hyderabad / Secunderabad

Job Description:

We, a Japanese CRO, are planning to establish the centre of Pharmacovigilance/Drug Safety in India. We have some openings of manager positions in Pharmacovigilance.
[Job Description]
In your responsible for the projects,

Support and Accompany with Sales in the USA/Japan for first several months and as necessary.
Setup a new centre of PV in India.
Provide your clients with the appropriate quality of services.
Write and amend company SOPs.
Prepare project KPI and monthly report.
Provide guidance and mentoring to less experienced/new staff members.
Prepare project KPI and monthly report.
Lead and support to change management and improve all processes.

[Information] Salary(CTC): Rs.55,000-60,000 lakh / month (Depends on experiences)
Travel allowance : Rs.2200/day in USA, Rs.1600/day in Japan

[Notifications] Interested candidates, please send your resume including:
Expected salary
Current and last drawn salaries (annual and monthly CTC)
Availability

Salary:INR 7,50,000 – 9,00,000 P.A. Travel allowance : Rs.2200/day in USA, Rs.1600/day in Japan
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category:Drug Regulatory Affairs/Documentation
Role:Regulatory Affairs Manager

Keyskills:

Pharmacovigilance Drug Safety PV Project Management

Desired Candidate Profile:

Education-

UG: B.Tech/B.E. – Bio-Chemistry/Bio-Technology, Biomedical, Chemical, B.Sc – Bio-Chemistry, Biology, Chemistry, Microbiology, Nursing, MBBS – Medicine, B.Pharma – Pharmacy
PG:M.Tech – Bio-Chemistry/Bio-Technology, Biomedical, Chemical, Post Graduation Not Required, M.Sc – Bio-Chemistry, Biology, Chemistry, Microbiology, Nursing, M.Pharma – Pharmacy, M.S/M.D – Any Specialization
Doctorate:Any Doctorate – Any Specialization, Doctorate Not Required

Job Requirements:
Min. 1 year of supervisory experience in handling a team of 5 to 20 members in Pharmacovigilance/Drug Safety projects.
Excellent interpersonal and presentation skills.
Demonstrated knowledge of pharmacovigilance regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.).
In-depth knowledge of Pharmacovigilance/Drug Safety SOPs.
Bachelor, MSc or equivalent in life sciences or a related field.
Ability to meet strict deadlines.
Presentation and report writing skills.
Demonstrate a positive and flexible working attitude.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Company Profile:

WDB Holdings Co., Ltd. / WDB Singapore Pte. Ltd.
Under WDB Holdings, we have main 4 Businesses and CRO Business is one of them and we are doing CRO/ARO services for Pharmaceuticals and Universities/National Hospitals in Japan.
Now, we would like to extend our business in USA and ASEAN area and be planning to establish the centre of Pharmacovigilance/Drug Safety in India.

Not Mentioned
Website:http://www.wdbhd.co.jp/eng/