::: Panacea Biotec :::

Careers:

Panacea Biotec is a leading research based Health Management Company, with an annual turnover of approx. Rs. 800 Crores. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.

We offer stimulating work environment & a career that spells growth. In tune with our plans, we require young, aggressive, dynamic, high performing and result oriented professional.

Designation	GM- Pharmaco vigilance
Job Description	Role & responsibility:
	1) Strategically lead the Global Pharmacovigilance Safety Team and pharmacovigilance development programs.
	2) Proactive identification of potential safety signals arising from clinical trials of drugs in development and from marketed products globally.
	3) Critically evaluating potential safety signals and where necessary developing strategies to enable further assessment of safety signals.
	4) Provide training and mentoring of Pharmacovigilance Physicians and Specialists.
	5) Develop risk management strategies for significant identified safety risks & provide drug safety and strategic inputs to clinical teams
	6) Provide medical input in periodic reporting documents including NDAs, sNDAs, (PSURs; Annual Safety Reports; etc.) Core Data Sheets, Investigator's Brochures, Clinical Study Reports, CTDs, Clinical Summaries, and Clinical Overviews (benefit-risk evaluation).
	7) Summarize the Pharmacovigilance activities performed by other departments that interface with pharmacovigilance (e.g. Medical Information, Regulatory Affairs and Product Quality).
	8) Process for spontaneous and clinical trial ADR management â from receipt to data entry, review and expedited reporting (if appropriate). It may be useful to provide flow diagrams(s) illustrating the information flow for safety reports of different origins and types.
	9) Prepare details of compliance monitoring activities.
	10) Form system for PSUR preparation and submission to competent authorities.
	11) Process for signal generation, trend evaluation and labeling changes.
	12) To keep track of Risk Management Plans
	13) To provide details of the computerized system(s)/database(s) used to collect, collate and evaluate information about suspected adverse reactions
Desired Profile	Skills/ Competencies:
	1) Excellent written and verbal communication skills; ability to write concise descriptive narrative summaries
	2) Knowledge of FDA/EMEA/CIOMS regulations/ guidance regarding clinical and post marketing pharmacovigilance.
	3) Experience with adverse event software (eg ARISg) and drug information is highly desirable
	4) Knowledge of global regulatory reporting requirements and GCP as well as GMP guidelines
	Critical Deliverables:
	1) Investigation of ADRs
	2) SPC/PIL updation with respect to safety update.
	3) Prescription information revision
	4) Periodic Safety Update Reports (PSURs)
	5) Adverse reports
	6) ADRs /Data Archival
	7) Risk management Plan
	8) Crisis Management
	9) Periodic Review of PV system
	10) PV database system and sops
Experience	8 - 11 Years
Industry Type	Pharma/ Biotech/Clinical Research
Functional Area	Healthcare, Medical, R&D
Education	UG - Any Graduate - Any Specialization
Education	PG - M.S/M.D - Any Specialization
Location	Delhi
Keywords	Pharma Covigilance
Contact	Mr. Anupam Roop Rai
Contact	Panacea Biotec Ltd
Email	hrd@panaceabiotec.com
Job Posted	Oct 11, 2008
Reference	0222/PAN/GM COVIGILANCE (Reference code must be mention in subject line)