Search Jobs

Manager - Pharmacovigilance

3 - 5 yrs
Apply without registration
Not Disclosed by Recruiter Openings: 1 Posted 11 days ago Job Applicants: Less than 10 Job Views: Less than 10

Job Description

 
Send me Jobs like this
    WHAT YOU DO:
    • Leads and manages the India, Nepal, Bangladesh and Bhutan Pharmacovigilance (PV) team.
    • Leads the local Safety Management Team and liaise with the relevant expert functions in the local Safety Risk Management Plan development and intervention implementation activities.
    • Provides guidance in all PV and safety matters:
    1. Is therefore actively participating in local safety issue and crisis management in collaboration with the Headquarter.
    2. Reviews the PV components of all domestic study protocols and informed consents and ensures that these parts are compliant with the PVstandards and the protocol template.
    3. Reviews all local patient support programs and other undertakings of the local organization with potential consequences on PV obligations (e.g.: Market Research, Active-Online-Listening programs) to ensure Pharmacovigilance principles are applied in all interactions with patients.
    • Represents Bayers PV system on a local level and for the countries in his/her jurisdiction, and keeps the global PV organization aware of relevant changes in the local context. This includes:
    1. Being accountable for all PV matter toward the local HA and the local organization.
    2. Being responsible to escalate any safety relevant matters and take respective actions to safeguards appropriately use and the benefit risk balance of Bayers' products on a local level.
    3. Review of local relevant medical literature according with the PV standard operations and procedures.
    4. Regular review and analysis of local regulatory context.
    • Assists in the maintenance of companys compliance with respect to laws, regulations and guidance associated with the licensure of Bayer medicinal products with respect to patient safety and assures the correct implementation and observation of all safety related Quality System Documents (QSD).
    • Education and training within the local organization; documentation of topics addressed during the training and of participants in the training.
    • Assures the collection, review, processing and distribution of adverse event information on a country level regarding the Bayer products in all therapeutic areas; guides submission of Individual Case Safety Reports to the local Health Authorities of the India, Nepal, Bangladesh and Bhutan according to the local regulations.
    • Act as Local SOP Responsible Person (LSRP). Encourage local collaboration on LQSD initiatives

    WHO YOU ARE:
    • Minimum of 3-5 years of experience in a (global) healthcare organization, especially in Clinical Development and/or Medical Affairs and/or Pharmacovigilance.
    • Knowledge in Pharmacovigilance relevant regulations.
    • Preferably in-depth experience in drug development process over different stages, especially clinical development and clinical operations.
    • Strong organizational, process and project management skills.
    • Strong financial reporting experience and skills and understanding of business systems.
    • Highly effective communicator with strong influencing ability.
    • Demonstrated ability to function effectively and successfully in a complex global and multicultural environment.
    • Ability to take personal responsibility and accountability.
    • Experience of leading and contributing to teams across cultures and geographies (if applicable).
    • Experience in development and authorship of complex Pharmacovigilance documents.
    • Experience of working across and building effective working relationships between functions.
    • Collaborative, team-oriented, flexible.

Salary: Not Disclosed by Recruiter

Industry: Pharma, Biotech, Clinical Research

Functional Area: Other

Role:Other

Employment Type: Full Time, Permanent

Keyskills

Education-

UG: MBBS - Medicine, BDS - Dentistry, B.Pharma - Pharmacy, BHMS - Any Specialization, BAMS - Any Specialization

PG:Any Postgraduate - Any Specialization

Company Profile:

Bayer Zydus Pharma Private Limited

Bayer is a Life Science company with a more than 150-year history and core competencies in the areas of health care and agriculture. With our innovative products, we are contributing to finding solutions to some of the major challenges of our time.
View Contact Details
Apply without registration

IEIL has taken all reasonable steps to ensure that information on this site is authentic. Applicants are advised to research bonafides of advertisers independently. IEIL shall not have any responsibility in this regard. We also recommend that you visit Security Guidelines and Terms and Conditions for more comprehensive information on this aspect.

-or-
Max 2MB, doc, docx, rtf, pdf
We will create your profile