PHARMACOVIGILANCE JOBS FOR B. PHARM / M. PHARM / PHARM.D / BAMS / BDS & LIFE SCIENCE CANDIDATES AT PHARMALEAF INDIA.

 PHARMALEAF INDIA PHARMACOVIGILANCE JOBS FOR B. PHARM / M. PHARM / PHARM.D / BAMS / BDS & LIFE SCIENCE CANDIDATES. 

 ABOUT PHARMALEAF INDIA:

Pharmaleaf India Pvt Ltd (a global regulatory organization, headquartered at Bangalore, India) Pharmaleaf's vision is to become the leading provider of International Regulatory, Quality Assurance & Technical support in terms of strategy, dossier management, filing and compliance throughout the lifecycle of the product. We aim to offer exceptional client service, quality, and speedy reviews while continuing to meet or exceed all Industry and regulatory quality standards.

JOB DETAILS:

Pharmaleaf India Pvt Ltd  is looking for a Dynamic and efficient Bachelor’s degree in life sciences or related field (Clinical, M.Pharm (Pharmacology, PharmD, BAMS/BDS) candidates for the position of “Regulatory Affairs & Pharmacovigilance Specialist” proficient in: Pharmacovigilance. Interested and eligible candidates can apply.

DEPARTMENTS: Regulatory Affairs & Pharmacovigilance

DESIGNATION: Regulatory Affairs & Pharmacovigilance Specialist

QUALIFICATION: Bachelor’s degree in life sciences or related field (Clinical, M.Pharm (Pharmacology, PharmD, BAMS/BDS).

KEY ATTRIBUTES:  Ability to prioritize, adhere to time-lines, problem solving capabilities, strong team and liaising skills.

EXPERIENCE:  3-5 years experience in Pharmacovigilance; Preferably from pharma establishment/company (Not CRO);

MARKET:  India

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JOB PROFILE: 

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members.

RESPONSIBILITIES:

1. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming:

2. To support Regulatory strategy for the execution of PV activities.

3. To assess & analyze timely processing of new and follow up reports of adverse effects & side-effects as well as SAE & Suspected and Unexpected Serious Adverse event Reaction (SUSARS))

4. Communication & Co-ordination with the Vendors, regulatory agencies & health care professionals.

5. To coordinate with cross functional teams to ensure PV compliance as per PvPi guidelines for marketed products.

6. To maintain PV data/databases.

7. To collect ADR report and submit to CDSCO, India and also to check for the precedence of the similar ADRs.

8. Well versed in literature search & extend PV support safety of the product.

9. Knowledge of PVPi module to prepare internal SOPS 10. Knowledge in RMP (Product risk management plan)

10. Knowledge in preparation of audit report

11. Publishing of the dossier in hardcopy and softcopy for submission at the agency. To submit the PSUR, DSUR, bi-annual status reports to CDSCO

12. Quality Control of the documents/dossier before dispatch or final submission on the Portal

13. Communication and Co-ordination with the Agency (Assistant Drug Controller/Drug Inspector CDSCO, SLA, IPC, FSSAI)

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LOCATION: Mumbai

SALARY: Attractive package and multinational exposure.

HOW TO APPLY:

If you think you are a fit or match reach out to us on: Email: cv@pharmaleaf.com

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MANKIND PHARMACEUTICALS MULTIPLE JOB OPENINGS FOR B. PHARM / M. PHARM / MSC IN QA AND QC DEPARTMENTS. 

MACLEODS PHARMACEUTICALS WALK IN INTERVIEW FOR QUALITY CONTROL AND QUALITY ASSURANCE DEPARTMENTS.