GSK Hiring for Manager, PV (Pharmacovigilance) Operations

GSK Hiring for Manager, PV (Pharmacovigilance) Operations

29 January, 2022

About the job

Site Name: Bengaluru Luxor North Tower

Posted Date: Jan 28 2022

Are you looking for a high-profile safety role that ensures the accuracy of critical safety data across multiple geographies? If so, this Safety Pharmacovigilance Manager role could be an ideal opportunity to explore.

As a Safety Pharmacovigilance Manager, you will manage the set-up, handover, and oversight of the Pharmacovigilance (PV) Hub’s various country requirements, ensuring high PV standards and following regulatory mandated requirements across designated country clusters. You will be responsible to ensure there is close alignment with respective General Managers (GMs) to ensure governance requirements.

These Responsibilities Include Some Of The Following

This role will provide YOU the opportunity to lead key activities to progress YOUR career.

  • Responsible for day to day management of Adverse Event (AE), incident and pregnancy reports for all countries within the Hub.
  • Accountable for exchange of safety data with licensing partners and maintenance of report files for local Safety Data Exchange (SDE) agreements as necessary.
  • Responsible for fulfilling local regulation for reporting to local regulatory authorities within mandated timeframes for expedited reports.
  • Ensure relevant training to authorized external third parties and internal stakeholders on literature review purposes, adverse event reporting, and medical information queries.
  • Notify CSD of any new GSK sponsored external facing websites that include free text facility.
  • Ensure a process is in place to identify and process AEs from websites including additional responsibility for medical information processes within the assigned country clusters.
  • Monitor locally published medical and scientific literature to identify reports which may not have been indexed on commercial or internal literature databases and for documenting the local literature review monthly.
  • Ensure there is an established process for liaison with the relevant departments dealing with product complaints and medical enquiries (in all countries).
  • Regular review of local product complaint log to ensure that AE, incident or pregnancy information reported in association with a product complaint or medical enquiry is notified to the Named Safety Contact (NSC).
  • Escalate issues to the relevant GSK CSD and Manufacturing Site Complaints Coordinator (in all countries).
  • Day to day management of AE, incident and pregnancy reports in GSK sponsored clinical studies within specific timeframes.
  • Notify the appropriate legal department and Head of the relevant CSD of any potential or actual legal action or liability with respect to human safety.
  • Responsible for governance of the Pharmacovigilance/Medical Information operations within designated clusters and coordination of central requests.
  • Serve as Internal GSK reference point of contact for Local Operating Companies (LOCs)/Rep Offices/Do Not Promote (DNP)/Direct to Government (DTG) and central teams.

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

  • PharmD (Pharmacists degree)
  • 2 or more years of experience working in the pharmaceutical industry
  • Experience in Pharmacovigilance and Medical Information regulatory requirements, systems, and processes
  • Experience with medical governance across multiple geographies

Preferred Qualifications

If you have the following characteristics, it would be a plus:

  • Doctor of Medicine (MD)
  • Strong collaboration, planning, execution, and communication skills
  • Ability to influence across a highly-matrixed organization

How to Apply?

Apply through below link

Manager, PV (Pharmacovigilance) Operations | GSK | LinkedIn

Why GSK?

As GSK Focuses On Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate The Following Capabilities

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.

GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKilne (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.

If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.

1Comments

Leave a Reply

Your email address will not be published. Required fields are marked *